Legal Manufacturer as a Service: Your legal manufacturer for medical devices in over 30 countries
As an experienced contract manufacturer, BAYOOCARE assumes full manufacturing responsibility for your medical device—from classification and CE marking to post-market surveillance. You focus on development and marketing; we take on overall regulatory responsibility.
What does Legal Manufacturer as a Service mean?
According to MDR and IVDR, a legal manufacturer is the person who places a medical device on the market under their own name, regardless of whether development and production have been outsourced. With our service, you can place medical devices on the market under your brand without having to set up a quality management system in accordance with ISO 13485 yourself. We assume legal responsibility for MDR conformity, manage communication with notified bodies and take care of product liability.
What we do for you
BAYOOCARE has been an expert in the market authorization of medical devices and in vitro diagnostics for over ten years. Our range of services is tailored specifically to your needs.
Still have questions? Please contact uswe know the answer.
Launch strategy:
From the product idea to market approval
We work with you to develop an individual launch strategy and create a concept with trend analyses and correct classification of the product classification. The classification of software medical devices according to Rule 11 of the MDR is particularly critical, as the risk class determines which conformity assessment procedure must be undergone. We analyze your intended purpose, evaluate the risk profile and define the optimal MDR compliance strategy for your target markets.
Distribution:
International market development
As a legal manufacturer in over 30 target countries, we organize the distribution of your medical device in various countries. With our offices in Darmstadt, Berlin, Munich, and Basel, we act as an EU Authorized Representative or CH-Rep (Swiss Authorized Representative). These Authorized Representative roles are a prerequisite for placing products on the market for manufacturers outside the respective markets.
Product liability:
Assume legal responsibility
As a legal manufacturer, we assume product liability and legal liability for your medical device. You can market your product under your brand without having to bear the full liability risk. With over ten years of experience – including our EU Regulation 2017/745 certificates for Class IIa (Companion Med App) and Class IIb (NeoDoppler) – we have all the necessary processes and insurance in place.
Hands-on support: practical support in quality management
As quality management representatives (QMRs), we support you with internal audits, conduct mock audits to help you prepare for certification audits, and assist you in setting up your QMS. We’re also here to support you with the Public Health Action Cycle (PHAC). This practical support is especially valuable for startups bringing a medical device to market for the first time.
Organization & communication with notified bodies
We organize and handle all communication with the notified body – in our case TÜV Süd. Thanks to our many years of cooperation, we know exactly what the expectations, processes and requirements are. For software medical devices, we manage to complete a full conformity assessment procedure within four weeks, without compromising on safety and quality.
Technical inspections
and testing
We coordinate the performance of technical tests by accredited test laboratories, for example electromagnetic compatibility (EMC), electrical safety in accordance with IEC 60601 or biocompatibility tests. We also carry out the necessary tests, including testing against alarm standards, software validation in accordance with IEC 62304 or usability tests in accordance with IEC 62366.
Vigilance, pharmacovigilance and post-market surveillance
We systematically monitor and assess risks after the product has been placed on the market. Our vigilance processes include the recording, evaluation and reporting of incidents to the responsible authorities as well as the coordination of Field Safety Corrective Actions (FSCA).
We carry out Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) for you: We continuously collect and analyze post-market data, evaluate trends, identify risks and initiate corrective actions. Our PMS framework includes the collection of customer feedback, complaint analysis, evaluation of scientific literature and systematic evaluation of clinical data.
Technical documentation: Complete, audit-proof, MDR-compliant
We create and maintain your technical documentation in accordance with MDR and IVDR Annex II and III, including the revision of existing documents.
Have you noticed that your Notified Body charges 425 euros per hour for the Tech Doc Review?
We offer a comprehensive preliminary review of your technical documentation before it is submitted to the notified body. This reduces queries, speeds up the review process and saves costs.
Our documentation includes all the necessary elements: device description, design and manufacturing information, full risk assessment, clinical evaluation, benefit-risk analysis and PMS and PMCF plans.
Our MDSAP and ISO 13485:2016 certification from TÜV Süd 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—saving you time and reducing the audit burden.
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.
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.
Our service is as individual as your requirements. Whether you are a MedTech start-up with an initial product idea, a pharmaceutical company adding medical devices to its portfolio or an established medical device manufacturer – we offer the right service. We support you in setting up a quality management system, classification and successful market approval.
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.
International market authorization raises many questions. We’ve answered the most common ones for you—from the role of the legal manufacturer to MDSAP certification and country-specific requirements. Can’t find your question here? Feel free to contact us.
