Services
Our services cover all activities throughout the product life cycle of medical devices.
Manufacture
From the initial idea to the re-audit
Support throughout all phases of the product life cycle for medical devices.
Learn more Manufacture
From the initial idea through to development, market compliance, market launch and market surveillance, right through to the re-audit, we support your project every step of the way.
Our range
- Classification of medical devices by intended purpose and risk class (MDR/IVDR)
- Preparation, review and maintenance of technical documentation
- Implementation and operation of an ISO 13485-certified quality management system
- Management of the conformity assessment process, including communication with notified bodies
- Post-market surveillance (PMS) and post-market clinical follow-up
- Vigilance and reporting to regulatory authorities
- Demonstration and verification of safety and performance requirements in accordance with the EU MDR
- Market surveillance
Our services
- Comprehensive project management from concept through development to market launch
- Assessment of technical feasibility
- Development of prototypes, drafting of the instructions for use, formulation of the intended purpose
- Risk classification under the AIMD: Class I, Class IIa and IIB, Class III and IVD
- Implementation of a quality management system
- Risk analysis and risk assessment
- Biocompatibility assessment
- Conducting pre-clinical trials
- Demonstration of performance and effectiveness through clinical trials and the evaluation of clinical data
- CE marking and issuance of the CE Declaration of Conformity
- Assumption of legal responsibility as the manufacturer, 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
- Production, including auditing of the production site
- Product testing
- Induction and further training for users
- Installation and maintenance
- Market and manufacturer monitoring
- Planning and conducting PMCF studies
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
Import and Export
EU and Swiss Representative
Access to the medical device market in the EU (EU-REP) and Switzerland (CH-REP).
Learn more Import and Export
As your EU-REP and CH-REP, we act as your legal liaison with the European authorities.
Our services
- Checking technical documentation for completeness and compliance
- Registration of manufacturers and products with EUDAMED and swissdamed
- 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
- Checking labelling against Swiss requirements (languages, formatting requirements)
Our services
- Designation as an EU-REP in accordance with Article 11 of the MDR / Article 10 of the IVDR
- Designation as a CH-REP in accordance with Article 51 of the MepV / Article 44 of the IvDV
- Provision of requested documentation to authorities
- Ongoing market surveillance and reporting obligations
- Extensive advice on classification, clinical evaluation and risk management
- Support with linguistic and labelling compliance adjustments
Your benefits
- Legally compliant market access throughout the EU and Switzerland 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
- Personalised support with short decision-making processes
Commercialisation
Making use of research findings
Licensing, commercialisation, placing on the market and marketing.
Learn more Commercialisation
We licence and commercialise your promising research.
Our services
- Technology Readiness Level (TRL) assessment and feasibility analysis
- Clarification of product classification and the appropriate conformity assessment route
- Provision of an ISO 13485-certified quality management system without the need for you to set it up yourself
- Assumption of the role of legal manufacturer, including designation as a PRRC
- Regulatory classification for funding applications (e.g. Innosuisse)
Our services
- Licensing and full assumption of commercial responsibility.
- Regulatory roadmap from research through to market authorisation.
- Preparation of technical documentation and clinical or performance evaluation.
- Acting as an EU and/or Swiss authorised representative for market access in the relevant markets.
- Regulatory support during discussions with investors and partners (due diligence readiness).
- Support during the transition from prototype to scalable, compliant series production.
Your benefits
- A faster route from publication to an authorised product
- No need to set up your own quality management system, PRRC function or regulatory affairs team
- Your work makes a difference to patients
- A single point of contact for scientific, regulatory and market access matters
Expertise
Consultancy services
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, conformity assessment 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
- Computer System Validation (CSV)
Our services
- Project-based or ongoing strategic and operational consultancy assignments
- Customised checklists and templates for your team
- Support with correspondence with regulatory authorities and submissions
- Interim assignments for the PRRC (Person Responsible for Regulatory Compliance)
Your benefits
- Building in-house regulatory expertise within your organisation
- Avoiding costly delays by preventing errors at an early stage
- Flexible collaboration
- Access to up-to-date practical knowledge
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Manufacture
From the initial idea to the re-audit
Support throughout all phases of the product life cycle for medical devices. -
Import and Export
EU and Swiss Representative
Access to the medical device market in the EU (EU-REP) and Switzerland (CH-REP). -
Commercialisation
Making use of research findings
Licensing, commercialisation, placing on the market and marketing. -
Expertise
Consultancy services
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 taken 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 taken 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.
