![](\"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 legal manufacturer, BAYOOCARE assumes full manufacturer responsibility for your medical device – from classification and CE marking to post-market surveillance. You concentrate on development and marketing, we take 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, navigate through MDR and IVDR and bring your product safely to market. In over 30 countries worldwide, with offices in Germany, Switzerland and the UK. <\/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 start-ups in the approval and marketing of medical devices and in-vitro diagnostics. Our team combines regulatory know-how, clinical expertise and practical project experience – in an area that leaves little room for error. <\/span><\/p>\nResponsibility as a service: <\/b>What sets us apart from traditional consultants: We not only provide consulting services, but also bear full regulatory responsibility for your product as a certified legal manufacturer. With our MDSAP and ISO 13485 certification from T\u00dcV S\u00fcd and ISO 27001 certification, we are equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb prove 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 by T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program enables simplified market approval in the five MDSAP countries: Australia, Brazil, Canada, Japan and USA. We cover the requirements of these important markets with a single audit – saving time and audit effort. <\/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 on ISO 13485 and expands it to include authority-specific requirements. The FDA, ANVISA (Brazil) and MHLW (Japan) accept MDSAP audit reports instead of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485, and Health Canada uses it to maintain its Canadian license. <\/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 our locations in Germany, Switzerland and the UK, we are ideally positioned for your international expansion. Thanks to our local presence, we are familiar with the specific requirements and regulatory peculiarities of the respective markets and can provide you with targeted support for your approval projects. <\/p>\n<\/div><\/div><\/div>
![\"BAYOOCARE](\"https:\/\/www.bayoocare.com\/wp-content\/uploads\/sites\/7\/2026\/04\/BAYOOCARE-Unsere-Standorte-in-Europa-UK-CH-EU.jpg\" "\\"BAYOOCARE")
<\/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>UK-Rep for Great Britain<\/h3><\/div><\/div>\nWith our location in London, we are taking on the role of UK Responsible Person for the British market after Brexit. We are familiar with the local requirements of the MHRA. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>FDA approval and US market<\/h3><\/div><\/div>\nOur MDSAP certification is an important building block for US market access, 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 approval raises many questions. We have answered the most common ones for you – from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Your question is not listed? Please 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 company or a legal manufacturer?<\/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 support the placing on the market?<\/span><\/a><\/h4><\/div>\nWe are active in over 30 target markets and operate from our locations in Germany, Switzerland and the UK as an EU authorized representative, CH-Rep and UK-Rep. Our MDSAP certification supports us in the US market. <\/p>\n<\/div><\/div><\/div>
As an experienced legal manufacturer, BAYOOCARE assumes full manufacturer responsibility for your medical device – from classification and CE marking to post-market surveillance. You concentrate on development and marketing, we take 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, navigate through MDR and IVDR and bring your product safely to market. In over 30 countries worldwide, with offices in Germany, Switzerland and the UK. <\/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 start-ups in the approval and marketing of medical devices and in-vitro diagnostics. Our team combines regulatory know-how, clinical expertise and practical project experience – in an area that leaves little room for error. <\/span><\/p>\nResponsibility as a service: <\/b>What sets us apart from traditional consultants: We not only provide consulting services, but also bear full regulatory responsibility for your product as a certified legal manufacturer. With our MDSAP and ISO 13485 certification from T\u00dcV S\u00fcd and ISO 27001 certification, we are equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb prove 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 by T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program enables simplified market approval in the five MDSAP countries: Australia, Brazil, Canada, Japan and USA. We cover the requirements of these important markets with a single audit – saving time and audit effort. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>MDSAP builds on ISO 13485 and expands it to include authority-specific requirements. The FDA, ANVISA (Brazil) and MHLW (Japan) accept MDSAP audit reports instead of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485, and Health Canada uses it to maintain its Canadian license. <\/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 our locations in Germany, Switzerland and the UK, we are ideally positioned for your international expansion. Thanks to our local presence, we are familiar with the specific requirements and regulatory peculiarities of the respective markets and can provide you with targeted support for your 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>UK-Rep for Great Britain<\/h3><\/div><\/div>\nWith our location in London, we are taking on the role of UK Responsible Person for the British market after Brexit. We are familiar with the local requirements of the MHRA. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>FDA approval and US market<\/h3><\/div><\/div>\nOur MDSAP certification is an important building block for US market access, 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 approval raises many questions. We have answered the most common ones for you – from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Your question is not listed? Please 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 company or a legal manufacturer?<\/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 support the placing on the market?<\/span><\/a><\/h4><\/div>\nWe are active in over 30 target markets and operate from our locations in Germany, Switzerland and the UK as an EU authorized representative, CH-Rep and UK-Rep. Our MDSAP certification supports us in the US market. <\/p>\n<\/div><\/div><\/div>
BAYOOCARE is your specialized partner for the regulatory approval of medical devices. We assume manufacturer responsibility, navigate through MDR and IVDR and bring your product safely to market. In over 30 countries worldwide, with offices in Germany, Switzerland and the UK. <\/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 start-ups in the approval and marketing of medical devices and in-vitro diagnostics. Our team combines regulatory know-how, clinical expertise and practical project experience – in an area that leaves little room for error. <\/span><\/p>\nResponsibility as a service: <\/b>What sets us apart from traditional consultants: We not only provide consulting services, but also bear full regulatory responsibility for your product as a certified legal manufacturer. With our MDSAP and ISO 13485 certification from T\u00dcV S\u00fcd and ISO 27001 certification, we are equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb prove 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 by T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program enables simplified market approval in the five MDSAP countries: Australia, Brazil, Canada, Japan and USA. We cover the requirements of these important markets with a single audit – saving time and audit effort. <\/p>\n<\/div><\/div><\/div>
<\/span><\/div><\/div><\/div>MDSAP builds on ISO 13485 and expands it to include authority-specific requirements. The FDA, ANVISA (Brazil) and MHLW (Japan) accept MDSAP audit reports instead of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485, and Health Canada uses it to maintain its Canadian license. <\/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 our locations in Germany, Switzerland and the UK, we are ideally positioned for your international expansion. Thanks to our local presence, we are familiar with the specific requirements and regulatory peculiarities of the respective markets and can provide you with targeted support for your 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>UK-Rep for Great Britain<\/h3><\/div><\/div>\nWith our location in London, we are taking on the role of UK Responsible Person for the British market after Brexit. We are familiar with the local requirements of the MHRA. <\/p>\n<\/div><\/div><\/div>
<\/i><\/span><\/div>FDA approval and US market<\/h3><\/div><\/div>\nOur MDSAP certification is an important building block for US market access, 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 approval raises many questions. We have answered the most common ones for you – from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Your question is not listed? Please 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 company or a legal manufacturer?<\/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 support the placing on the market?<\/span><\/a><\/h4><\/div>\nWe are active in over 30 target markets and operate from our locations in Germany, Switzerland and the UK as an EU authorized representative, CH-Rep and UK-Rep. Our MDSAP certification supports us in the US market. <\/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 start-ups in the approval and marketing of medical devices and in-vitro diagnostics. Our team combines regulatory know-how, clinical expertise and practical project experience – in an area that leaves little room for error. <\/span><\/p>\n Responsibility as a service: <\/b>What sets us apart from traditional consultants: We not only provide consulting services, but also bear full regulatory responsibility for your product as a certified legal manufacturer. With our MDSAP and ISO 13485 certification from T\u00dcV S\u00fcd and ISO 27001 certification, we are equipped for all relevant markets. Our EU Regulation 2017\/745 certificates for Class IIa and Class IIb prove 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 by T\u00dcV S\u00fcd offers you strategic advantages for international expansion. The Medical Device Single Audit Program enables simplified market approval in the five MDSAP countries: Australia, Brazil, Canada, Japan and USA. We cover the requirements of these important markets with a single audit – saving time and audit effort. <\/p>\n<\/div><\/div><\/div> MDSAP builds on ISO 13485 and expands it to include authority-specific requirements. The FDA, ANVISA (Brazil) and MHLW (Japan) accept MDSAP audit reports instead of their own audits. The Australian TGA accepts the MDSAP certificate as proof of ISO 13485, and Health Canada uses it to maintain its Canadian license. <\/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 our locations in Germany, Switzerland and the UK, we are ideally positioned for your international expansion. Thanks to our local presence, we are familiar with the specific requirements and regulatory peculiarities of the respective markets and can provide you with targeted support for your 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> With our location in London, we are taking on the role of UK Responsible Person for the British market after Brexit. We are familiar with the local requirements of the MHRA. <\/p>\n<\/div><\/div><\/div> Our MDSAP certification is an important building block for US market access, 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 approval raises many questions. We have answered the most common ones for you – from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Your question is not listed? Please 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 are active in over 30 target markets and operate from our locations in Germany, Switzerland and the UK as an EU authorized representative, CH-Rep and UK-Rep. Our MDSAP certification supports us in the US market. <\/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>
UK-Rep for Great Britain<\/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 company or a legal manufacturer?<\/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 support the placing on the market?<\/span><\/a><\/h4><\/div>