Services
Our services cover all activities throughout the product life cycle of medical devices.
Placing on the market
Authorised manufacturer
Manufacture of medical devices.
Learn more Placing on the market
You develop and market your product, and we assume full manufacturer responsibility in accordance with the MDR/IVDR. As the legal manufacturer, we place your medical device on the market in compliance with all regulatory obligations, without you having to set up a certified quality management system yourself.
Our range
- Classification of the product according to intended purpose and risk class (MDR/IVDR)
- Preparation, review and maintenance of the technical documentation
- Implementation and operation of an ISO 13485-certified quality management system
- Management of the conformity assessment, including communication with notified bodies
- Post-market surveillance (PMS) and post-market clinical follow-up
- Vigilance and reporting to regulatory authorities
Our services
- Comprehensive project management from planning through to market authorisation
- Assumption of legal manufacturer responsibility, including product liability issues
- Ongoing updating of documentation in line with regulatory changes
- Liaison with suppliers, testing laboratories and certification bodies
- Continuous risk management throughout the entire product life cycle
Your benefits
- Market access without having to set up your own quality management system
- Reduced liability risk thanks to clearly defined responsibilities
- Faster time-to-market thanks to established processes and contacts with regulatory authorities
- You retain your focus on development and sales
EU market
EU Representative
Access to the EU medical device market (EU-REP).
Learn more EU market
Manufacturers based outside the EU require an EU Authorised Representative in order to place their medical devices on the market. As your EU Authorised Representative, we act as the legal point of contact with the European authorities.
Our services
- Checking technical documentation for completeness and compliance
- Registration of manufacturers and products with EUDAMED
- Management of the EU Declaration of Conformity and CE marking
- Communication with the relevant national authorities in the event of enquiries
- Forwarding of vigilance reports and support with corrective actions
Our services
- Appointment as an EU Authorised Representative in accordance with Article 11 of the MDR / Article 10 of the IVDR
- Provision of requested documentation to authorities
- Ongoing market surveillance and reporting obligations
- Comprehensive advice on classification, clinical evaluation and risk management
Your benefits
- Legally compliant market access across the entire EU via a central representative
- Relief from administrative and regulatory burdens
- An experienced team with expertise in sector-specific regulatory requirements
- Scalable for individual products or entire product portfolios
Swiss market
Swiss Representative
Access to the Swiss medical devices market (CH-REP).
Learn more Swiss market
A Swiss authorised representative is essential for foreign manufacturers not based in Switzerland. We represent you in dealings with Swissmedic and ensure that your product meets all the requirements of the MepV and IvDV.
Our services
- Verification of technical documentation and quality management systems in accordance with MepV/IvDV
- Verification of labelling in accordance with Swiss requirements (languages, formatting requirements)
- Registration of manufacturers, authorised representatives and products with Swissmedic (swissdamed)
- Collaboration with Swissmedic on audits, preventive and corrective actions
- Coordination with Swiss importers and distributors
Our services
- Appointment as a CH-REP in accordance with Art. 51 MepV / Art. 44 IvDV
- Ongoing market surveillance and reporting in Switzerland
- Support with linguistic and labelling compliance adjustments
- Multilingual support (German, French, Italian, English)
Your benefits
- Direct, compliant access to the Swiss market without the need for your own branch
- Personalised support with short decision-making processes
- Proven high standards of compliance (inspection-tested processes)
- Ideal for combining with an EU-REP mandate for dual marketing in the EU and Switzerland
Expertise
Regulatory advice
Ad hoc and project-based support.
Learn more Expertise
We provide support in areas where you currently lack the capacity: from initial classification through to development and ongoing market monitoring.
Our services
- Gap analyses of existing technical documentation and quality management systems
- Advice on classification, compliance pathway and certification strategy
- Support with clinical evaluation and performance evaluation (IVD)
- Preparation for audits by Notified Bodies and regulatory authorities
- Training on the MDR, IVDR, MepV and IvDV
Our services
- Project-based or ongoing consultancy mandates
- Customised checklists and templates for your team
- Support with correspondence with regulatory authorities and submissions
- Interim appointments for the PRRC (Person Responsible for Regulatory Compliance)
Benefits
- Building in-house regulatory expertise within the company
- Avoiding costly delays by preventing errors at an early stage
- Flexible collaboration
- Access to up-to-date practical knowledge
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Placing on the market
Authorised manufacturer
Manufacture of medical devices. -
EU market
EU Representative
Access to the EU medical device market (EU-REP). -
Swiss market
Swiss Representative
Access to the Swiss medical devices market (CH-REP). -
Expertise
Regulatory advice
Ad hoc and project-based support.
Your benefits
-
Legal certainty in the EU and Switzerland
Compliance with the requirements of the MDR, IVDR, MepV and IvDV is non-negotiable. With our support, your product will remain compliant in both markets. -
Faster market access
Thanks to our well-established processes, direct contacts with the relevant authorities and a well-coordinated team, we significantly reduce the time from development to market approval. -
For businesses of all sizes
Our services grow in line with your needs, whether you’re a start-up or a large corporation. -
Everything from a single source
Manufacturing, legal manufacturing, EU representation and Swiss representation do not run in parallel at our company, but are fully integrated. You benefit from a well-coordinated team, a quality management system and a single point of contact.
-
Legal certainty in the EU and Switzerland
Compliance with the requirements of the MDR, IVDR, MepV and IvDV is non-negotiable. With our support, your product will remain compliant in both markets.
-
Faster market access
Thanks to our well-established processes, direct contacts with the relevant authorities and a well-coordinated team, we significantly reduce the time from development to market approval.
-
For businesses of all sizes
Our services grow in line with your needs, whether you’re a start-up or a large corporation.
-
Everything from a single source
Manufacturing, legal manufacturing, EU representation and Swiss representation do not run in parallel at our company, but are fully integrated. You benefit from a well-coordinated team, a quality management system and a single point of contact.
Ensuring compliance
Benefit from our experience in placing medical devices on the market, preparing technical documentation, implementing quality management systems and representing your interests in dealings with regulatory authorities and Notified Bodies – simply describe your requirements. We will find a suitable solution.