![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/02\/Startseite-Platzhalter-KI-generiert-scaled.jpg\" "\\"Startseite")
<\/span><\/div><\/div><\/div>Legal Manufacturer as a Service: Your legal manufacturer for medical devices in over 30 countries<\/h2><\/div>As an experienced contract manufacturer, BAYOOCARE assumes full manufacturing responsibility for your medical device\u2014from classification and CE marking to post-market surveillance. You focus on development and marketing; we take on overall regulatory responsibility. <\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div><\/div><\/div>About us<\/h1><\/div>BAYOOCARE is your specialized partner for the regulatory approval of medical devices. We assume manufacturer responsibility, guide you through the MDR and IVDR, and bring your product to market safely. We operate in over 30 countries worldwide, with offices in Germany and Switzerland. <\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div>![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE_About-us-1024x585.jpg\" "\\"BAYOOCARE_About")
<\/span><\/div><\/div><\/div><\/div><\/div>Who we are<\/h2><\/div>Regulatory experts with practical experience: <\/b>BAYOOCARE is a company within the BAYOONET Group that specializes in medical devices. For over ten years, we have been supporting medtech companies, pharmaceutical companies, and startups with the approval and marketing of medical devices and in vitro diagnostic devices. Our team combines regulatory know-how, clinical expertise, and practical project experience\u2014in a field that leaves little room for error. <\/span><\/p>\nResponsibility as a service: <\/b>What sets us apart from traditional consultants: We don\u2019t just provide consulting services; as a certified legal manufacturer, we assume full regulatory responsibility for your product. With our MDSAP and ISO 13485 certifications from T\u00dcV S\u00fcd, as well as our ISO 27001 certification, we are well-equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb demonstrate that we live up to this responsibility every day. <\/span><\/p>\n<\/div><\/div><\/div>![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/03\/Alfred-Koch.png\" "\\"Alfred-Koch\\"")
<\/span><\/div>Alfred Koch<\/h3><\/div>CEO | PRRC
info@bayoo.net
+49 (0) 6151 8618 0<\/p>\n<\/div><\/div><\/div>
This is how we work<\/h2><\/div>Regulatory Affairs is not an end in itself. We think in terms of your product: What does it need to get onto the market? What does it need to stay there? We are not consultants at a distance, but a reliable part of your team. Pragmatic, because we know that time is a scarce resource in MedTech development. Personally, because regulatory responsibility requires trust. And holistic, because compliance is not a project, but an ongoing process. <\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/14.jpg\" "\\"14\\"")
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
Pragmatic<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Personal<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Responsible<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Internationally positioned<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Holistic<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Quick<\/p>\n<\/div><\/li><\/ul>
Still have questions?<\/b> Please contact us<\/u><\/a>we know the answer.<\/span><\/p>\n<\/div><\/div><\/div>Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Our certifications<\/h2><\/div><\/div><\/div>Our MDSAP and ISO 13485:2016 certification from T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program facilitates market authorization in the five MDSAP countries: Australia, Brazil, Canada, Japan, and the United States. With a single audit, we cover the requirements of these key markets\u2014saving you time and reducing the audit burden. <\/p>\n<\/div><\/div><\/div>
![\"BAYOOCARE](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Wir-sind-MDSAP-und-TUeV-zertifiziert.png\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>MDSAP builds upon ISO 13485 and expands upon it with regulatory-specific requirements. The FDA, ANVISA (Brazil), and MHLW (Japan) accept MDSAP audit reports in lieu of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485 compliance, and Health Canada uses it to maintain Canadian licensing. <\/span><\/p>\nOur ISO 27001 certification proves that we systematically manage information security – centrally for digital health applications and software medical devices that process personal health data. We ensure that your technical documentation meets all requirements for GDPR, data security and the basic security and performance requirements. <\/p>\n<\/div><\/div><\/div>
Our locations<\/h2><\/div><\/div><\/div>With offices in Germany and Switzerland, we are ideally positioned to support your international expansion. Thanks to our local presence, we understand the specific requirements and regulatory nuances of each market and can provide you with targeted support for your regulatory approval projects. <\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/07\/BAYOOCARE-Unsere-Standorte-in-Europa-CH-EU-1024x1024.png\" "\\"BAYOOCARE-Unsere-Standorte-in-Europa-CH-EU\\"")
<\/span><\/div><\/div><\/div><\/i><\/span><\/div>EU Authorized Representative (EU Rep)<\/h3><\/div><\/div>\nWith offices in Darmstadt, Berlin and Munich, we act as a legal manufacturer or EU authorized representative and take on all necessary tasks for placing on the market<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>CH-Rep for Switzerland<\/h3><\/div><\/div>\nOur location in Basel acts as an interface to Swissmedic. We provide support with registrations, are named on the label and keep the technical documentation available on site. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>FDA approval and US market<\/h3><\/div><\/div>\nOur MDSAP certification is a key component for gaining access to the U.S. market, as the FDA recognizes MDSAP audit reports. We support you in preparing for FDA approval and advise you on the requirements of the Quality System Regulation (QSR). <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>International market authorization raises many questions. We\u2019ve answered the most common ones for you\u2014from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Can\u2019t find your question here? Feel free to contact us. <\/p>\n<\/div><\/div><\/div>
![](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2025\/01\/BAYOOCARE-Favicon.png\" "\\"BAYOOCARE")
<\/span><\/div><\/div><\/div>General Information About BAYOOCARE<\/h3><\/div><\/i><\/i><\/span>Is BAYOOCARE a consulting firm or a legal services provider?<\/span><\/a><\/h4><\/div>\nBoth – depending on your needs. We offer traditional consulting services in the area of regulatory affairs, but we can also assume full manufacturer responsibility for your product. We will clarify exactly what makes sense in an initial meeting. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Who is BAYOOCARE the right partner for?<\/span><\/a><\/h4><\/div>\nFor MedTech companies, pharmaceutical companies with medical device ambitions and start-ups alike. Whether it’s your first product or international expansion – we tailor our services to your situation. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>In which countries can BAYOOCARE assist with market authorization?<\/span><\/a><\/h4><\/div>\nWe operate in over 30 target markets and, through our locations in Germany and Switzerland, act as an EU Authorized Representative and Swiss Representative. Our MDSAP certification supports our operations in the U.S. market. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it actually mean when BAYOOCARE assumes the role of legal manufacturer?<\/span><\/a><\/h4><\/div>\nWe place your product on the market under our name and bear full regulatory and legal responsibility – including product liability, technical documentation, post-market surveillance and communication with the notified body. You focus on your product, we focus on compliance. <\/p>\n<\/div><\/div><\/div>
As an experienced contract manufacturer, BAYOOCARE assumes full manufacturing responsibility for your medical device\u2014from classification and CE marking to post-market surveillance. You focus on development and marketing; we take on overall regulatory responsibility. <\/p>\n<\/div>
About us<\/h1><\/div>BAYOOCARE is your specialized partner for the regulatory approval of medical devices. We assume manufacturer responsibility, guide you through the MDR and IVDR, and bring your product to market safely. We operate in over 30 countries worldwide, with offices in Germany and Switzerland. <\/p>\n<\/div>
Contact us now<\/span><\/a><\/div><\/div><\/div><\/span><\/div><\/div><\/div><\/div><\/div>Who we are<\/h2><\/div>Regulatory experts with practical experience: <\/b>BAYOOCARE is a company within the BAYOONET Group that specializes in medical devices. For over ten years, we have been supporting medtech companies, pharmaceutical companies, and startups with the approval and marketing of medical devices and in vitro diagnostic devices. Our team combines regulatory know-how, clinical expertise, and practical project experience\u2014in a field that leaves little room for error. <\/span><\/p>\nResponsibility as a service: <\/b>What sets us apart from traditional consultants: We don\u2019t just provide consulting services; as a certified legal manufacturer, we assume full regulatory responsibility for your product. With our MDSAP and ISO 13485 certifications from T\u00dcV S\u00fcd, as well as our ISO 27001 certification, we are well-equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb demonstrate that we live up to this responsibility every day. <\/span><\/p>\n<\/div><\/div><\/div><\/span><\/div>Alfred Koch<\/h3><\/div>CEO | PRRC
info@bayoo.net
+49 (0) 6151 8618 0<\/p>\n<\/div><\/div><\/div>
This is how we work<\/h2><\/div>Regulatory Affairs is not an end in itself. We think in terms of your product: What does it need to get onto the market? What does it need to stay there? We are not consultants at a distance, but a reliable part of your team. Pragmatic, because we know that time is a scarce resource in MedTech development. Personally, because regulatory responsibility requires trust. And holistic, because compliance is not a project, but an ongoing process. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
Pragmatic<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Personal<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Responsible<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Internationally positioned<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Holistic<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Quick<\/p>\n<\/div><\/li><\/ul>
Still have questions?<\/b> Please contact us<\/u><\/a>we know the answer.<\/span><\/p>\n<\/div><\/div><\/div>Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Our certifications<\/h2><\/div><\/div><\/div>Our MDSAP and ISO 13485:2016 certification from T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program facilitates market authorization in the five MDSAP countries: Australia, Brazil, Canada, Japan, and the United States. With a single audit, we cover the requirements of these key markets\u2014saving you time and reducing the audit burden. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>MDSAP builds upon ISO 13485 and expands upon it with regulatory-specific requirements. The FDA, ANVISA (Brazil), and MHLW (Japan) accept MDSAP audit reports in lieu of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485 compliance, and Health Canada uses it to maintain Canadian licensing. <\/span><\/p>\nOur ISO 27001 certification proves that we systematically manage information security – centrally for digital health applications and software medical devices that process personal health data. We ensure that your technical documentation meets all requirements for GDPR, data security and the basic security and performance requirements. <\/p>\n<\/div><\/div><\/div>
Our locations<\/h2><\/div><\/div><\/div>With offices in Germany and Switzerland, we are ideally positioned to support your international expansion. Thanks to our local presence, we understand the specific requirements and regulatory nuances of each market and can provide you with targeted support for your regulatory approval projects. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/i><\/span><\/div>EU Authorized Representative (EU Rep)<\/h3><\/div><\/div>\nWith offices in Darmstadt, Berlin and Munich, we act as a legal manufacturer or EU authorized representative and take on all necessary tasks for placing on the market<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>CH-Rep for Switzerland<\/h3><\/div><\/div>\nOur location in Basel acts as an interface to Swissmedic. We provide support with registrations, are named on the label and keep the technical documentation available on site. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>FDA approval and US market<\/h3><\/div><\/div>\nOur MDSAP certification is a key component for gaining access to the U.S. market, as the FDA recognizes MDSAP audit reports. We support you in preparing for FDA approval and advise you on the requirements of the Quality System Regulation (QSR). <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>International market authorization raises many questions. We\u2019ve answered the most common ones for you\u2014from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Can\u2019t find your question here? Feel free to contact us. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>General Information About BAYOOCARE<\/h3><\/div><\/i><\/i><\/span>Is BAYOOCARE a consulting firm or a legal services provider?<\/span><\/a><\/h4><\/div>\nBoth – depending on your needs. We offer traditional consulting services in the area of regulatory affairs, but we can also assume full manufacturer responsibility for your product. We will clarify exactly what makes sense in an initial meeting. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Who is BAYOOCARE the right partner for?<\/span><\/a><\/h4><\/div>\nFor MedTech companies, pharmaceutical companies with medical device ambitions and start-ups alike. Whether it’s your first product or international expansion – we tailor our services to your situation. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>In which countries can BAYOOCARE assist with market authorization?<\/span><\/a><\/h4><\/div>\nWe operate in over 30 target markets and, through our locations in Germany and Switzerland, act as an EU Authorized Representative and Swiss Representative. Our MDSAP certification supports our operations in the U.S. market. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it actually mean when BAYOOCARE assumes the role of legal manufacturer?<\/span><\/a><\/h4><\/div>\nWe place your product on the market under our name and bear full regulatory and legal responsibility – including product liability, technical documentation, post-market surveillance and communication with the notified body. You focus on your product, we focus on compliance. <\/p>\n<\/div><\/div><\/div>
BAYOOCARE is your specialized partner for the regulatory approval of medical devices. We assume manufacturer responsibility, guide you through the MDR and IVDR, and bring your product to market safely. We operate in over 30 countries worldwide, with offices in Germany and Switzerland. <\/p>\n<\/div>
<\/span><\/div><\/div><\/div><\/div><\/div>Who we are<\/h2><\/div>Regulatory experts with practical experience: <\/b>BAYOOCARE is a company within the BAYOONET Group that specializes in medical devices. For over ten years, we have been supporting medtech companies, pharmaceutical companies, and startups with the approval and marketing of medical devices and in vitro diagnostic devices. Our team combines regulatory know-how, clinical expertise, and practical project experience\u2014in a field that leaves little room for error. <\/span><\/p>\nResponsibility as a service: <\/b>What sets us apart from traditional consultants: We don\u2019t just provide consulting services; as a certified legal manufacturer, we assume full regulatory responsibility for your product. With our MDSAP and ISO 13485 certifications from T\u00dcV S\u00fcd, as well as our ISO 27001 certification, we are well-equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb demonstrate that we live up to this responsibility every day. <\/span><\/p>\n<\/div><\/div><\/div><\/span><\/div>Alfred Koch<\/h3><\/div>CEO | PRRC
info@bayoo.net
+49 (0) 6151 8618 0<\/p>\n<\/div><\/div><\/div>
This is how we work<\/h2><\/div>Regulatory Affairs is not an end in itself. We think in terms of your product: What does it need to get onto the market? What does it need to stay there? We are not consultants at a distance, but a reliable part of your team. Pragmatic, because we know that time is a scarce resource in MedTech development. Personally, because regulatory responsibility requires trust. And holistic, because compliance is not a project, but an ongoing process. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>- <\/i><\/span>\n
Pragmatic<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Personal<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Responsible<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Internationally positioned<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Holistic<\/p>\n<\/div><\/li>
- <\/i><\/span>\n
Quick<\/p>\n<\/div><\/li><\/ul>
Still have questions?<\/b> Please contact us<\/u><\/a>we know the answer.<\/span><\/p>\n<\/div><\/div><\/div>Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Our certifications<\/h2><\/div><\/div><\/div>Our MDSAP and ISO 13485:2016 certification from T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program facilitates market authorization in the five MDSAP countries: Australia, Brazil, Canada, Japan, and the United States. With a single audit, we cover the requirements of these key markets\u2014saving you time and reducing the audit burden. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>MDSAP builds upon ISO 13485 and expands upon it with regulatory-specific requirements. The FDA, ANVISA (Brazil), and MHLW (Japan) accept MDSAP audit reports in lieu of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485 compliance, and Health Canada uses it to maintain Canadian licensing. <\/span><\/p>\nOur ISO 27001 certification proves that we systematically manage information security – centrally for digital health applications and software medical devices that process personal health data. We ensure that your technical documentation meets all requirements for GDPR, data security and the basic security and performance requirements. <\/p>\n<\/div><\/div><\/div>
Our locations<\/h2><\/div><\/div><\/div>With offices in Germany and Switzerland, we are ideally positioned to support your international expansion. Thanks to our local presence, we understand the specific requirements and regulatory nuances of each market and can provide you with targeted support for your regulatory approval projects. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div><\/i><\/span><\/div>EU Authorized Representative (EU Rep)<\/h3><\/div><\/div>\nWith offices in Darmstadt, Berlin and Munich, we act as a legal manufacturer or EU authorized representative and take on all necessary tasks for placing on the market<\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>CH-Rep for Switzerland<\/h3><\/div><\/div>\nOur location in Basel acts as an interface to Swissmedic. We provide support with registrations, are named on the label and keep the technical documentation available on site. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>FDA approval and US market<\/h3><\/div><\/div>\nOur MDSAP certification is a key component for gaining access to the U.S. market, as the FDA recognizes MDSAP audit reports. We support you in preparing for FDA approval and advise you on the requirements of the Quality System Regulation (QSR). <\/p>\n<\/div><\/div><\/div>
<\/div><\/div><\/div><\/div>Contact us<\/h3><\/div>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div>
Your contact to us<\/span><\/a><\/div><\/div><\/div><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Frequently asked questions<\/h2><\/div><\/div><\/div>International market authorization raises many questions. We\u2019ve answered the most common ones for you\u2014from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Can\u2019t find your question here? Feel free to contact us. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>General Information About BAYOOCARE<\/h3><\/div><\/i><\/i><\/span>Is BAYOOCARE a consulting firm or a legal services provider?<\/span><\/a><\/h4><\/div>\nBoth – depending on your needs. We offer traditional consulting services in the area of regulatory affairs, but we can also assume full manufacturer responsibility for your product. We will clarify exactly what makes sense in an initial meeting. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>Who is BAYOOCARE the right partner for?<\/span><\/a><\/h4><\/div>\nFor MedTech companies, pharmaceutical companies with medical device ambitions and start-ups alike. Whether it’s your first product or international expansion – we tailor our services to your situation. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>In which countries can BAYOOCARE assist with market authorization?<\/span><\/a><\/h4><\/div>\nWe operate in over 30 target markets and, through our locations in Germany and Switzerland, act as an EU Authorized Representative and Swiss Representative. Our MDSAP certification supports our operations in the U.S. market. <\/p>\n<\/div><\/div><\/div>
<\/i><\/i><\/span>What does it actually mean when BAYOOCARE assumes the role of legal manufacturer?<\/span><\/a><\/h4><\/div>\nWe place your product on the market under our name and bear full regulatory and legal responsibility – including product liability, technical documentation, post-market surveillance and communication with the notified body. You focus on your product, we focus on compliance. <\/p>\n<\/div><\/div><\/div>
Regulatory experts with practical experience: <\/b>BAYOOCARE is a company within the BAYOONET Group that specializes in medical devices. For over ten years, we have been supporting medtech companies, pharmaceutical companies, and startups with the approval and marketing of medical devices and in vitro diagnostic devices. Our team combines regulatory know-how, clinical expertise, and practical project experience\u2014in a field that leaves little room for error. <\/span><\/p>\n Responsibility as a service: <\/b>What sets us apart from traditional consultants: We don\u2019t just provide consulting services; as a certified legal manufacturer, we assume full regulatory responsibility for your product. With our MDSAP and ISO 13485 certifications from T\u00dcV S\u00fcd, as well as our ISO 27001 certification, we are well-equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb demonstrate that we live up to this responsibility every day. <\/span><\/p>\n<\/div><\/div><\/div> CEO | PRRC Regulatory Affairs is not an end in itself. We think in terms of your product: What does it need to get onto the market? What does it need to stay there? We are not consultants at a distance, but a reliable part of your team. Pragmatic, because we know that time is a scarce resource in MedTech development. Personally, because regulatory responsibility requires trust. And holistic, because compliance is not a project, but an ongoing process. <\/p>\n<\/div><\/div><\/div> Pragmatic<\/p>\n<\/div><\/li> Personal<\/p>\n<\/div><\/li> Responsible<\/p>\n<\/div><\/li> Internationally positioned<\/p>\n<\/div><\/li> Holistic<\/p>\n<\/div><\/li> Quick<\/p>\n<\/div><\/li><\/ul> Still have questions?<\/b> Please contact us<\/u><\/a>we know the answer.<\/span><\/p>\n<\/div><\/div><\/div> Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div> Our MDSAP and ISO 13485:2016 certification from T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program facilitates market authorization in the five MDSAP countries: Australia, Brazil, Canada, Japan, and the United States. With a single audit, we cover the requirements of these key markets\u2014saving you time and reducing the audit burden. <\/p>\n<\/div><\/div><\/div> MDSAP builds upon ISO 13485 and expands upon it with regulatory-specific requirements. The FDA, ANVISA (Brazil), and MHLW (Japan) accept MDSAP audit reports in lieu of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485 compliance, and Health Canada uses it to maintain Canadian licensing. <\/span><\/p>\n Our ISO 27001 certification proves that we systematically manage information security – centrally for digital health applications and software medical devices that process personal health data. We ensure that your technical documentation meets all requirements for GDPR, data security and the basic security and performance requirements. <\/p>\n<\/div><\/div><\/div> With offices in Germany and Switzerland, we are ideally positioned to support your international expansion. Thanks to our local presence, we understand the specific requirements and regulatory nuances of each market and can provide you with targeted support for your regulatory approval projects. <\/p>\n<\/div><\/div><\/div> With offices in Darmstadt, Berlin and Munich, we act as a legal manufacturer or EU authorized representative and take on all necessary tasks for placing on the market<\/p>\n<\/div><\/div><\/div> Our location in Basel acts as an interface to Swissmedic. We provide support with registrations, are named on the label and keep the technical documentation available on site. <\/p>\n<\/div><\/div><\/div> Our MDSAP certification is a key component for gaining access to the U.S. market, as the FDA recognizes MDSAP audit reports. We support you in preparing for FDA approval and advise you on the requirements of the Quality System Regulation (QSR). <\/p>\n<\/div><\/div><\/div> Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device. <\/p>\n<\/div> International market authorization raises many questions. We\u2019ve answered the most common ones for you\u2014from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Can\u2019t find your question here? Feel free to contact us. <\/p>\n<\/div><\/div><\/div> Both – depending on your needs. We offer traditional consulting services in the area of regulatory affairs, but we can also assume full manufacturer responsibility for your product. We will clarify exactly what makes sense in an initial meeting. <\/p>\n<\/div><\/div><\/div> For MedTech companies, pharmaceutical companies with medical device ambitions and start-ups alike. Whether it’s your first product or international expansion – we tailor our services to your situation. <\/p>\n<\/div><\/div><\/div> We operate in over 30 target markets and, through our locations in Germany and Switzerland, act as an EU Authorized Representative and Swiss Representative. Our MDSAP certification supports our operations in the U.S. market. <\/p>\n<\/div><\/div><\/div> We place your product on the market under our name and bear full regulatory and legal responsibility – including product liability, technical documentation, post-market surveillance and communication with the notified body. You focus on your product, we focus on compliance. <\/p>\n<\/div><\/div><\/div><\/span><\/div>Alfred Koch<\/h3><\/div>
info@bayoo.net
+49 (0) 6151 8618 0<\/p>\n<\/div><\/div><\/div>This is how we work<\/h2><\/div>
<\/span><\/div><\/div><\/div>Contact us<\/h3><\/div>
Our certifications<\/h2><\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>Our locations<\/h2><\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>EU Authorized Representative (EU Rep)<\/h3><\/div>
CH-Rep for Switzerland<\/h3><\/div>
FDA approval and US market<\/h3><\/div>
Contact us<\/h3><\/div>
Frequently asked questions<\/h2><\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>General Information About BAYOOCARE<\/h3><\/div>
<\/i><\/i><\/span>Is BAYOOCARE a consulting firm or a legal services provider?<\/span><\/a><\/h4><\/div>
<\/i><\/i><\/span>Who is BAYOOCARE the right partner for?<\/span><\/a><\/h4><\/div>
<\/i><\/i><\/span>In which countries can BAYOOCARE assist with market authorization?<\/span><\/a><\/h4><\/div>
<\/i><\/i><\/span>What does it actually mean when BAYOOCARE assumes the role of legal manufacturer?<\/span><\/a><\/h4><\/div>