Medical devices · Combination products
Complex requirements. A clear way forward.
Move your medical device project forward with a senior Swiss consultant and the specialist team your challenge needs. From regulatory strategy to documentation and market access.
Trusted by leading medical device and pharmaceutical industry leaders
Expertise, organized around you
What are you working towards?
Start with your challenge. Explore the expertise and deliverables that can move your project forward.
11 services
UDI Compliance
EUDAMED & GUDID registration, labeling integration, and direct marking solutions
Learn more — UDI Compliance
Technical Documentation & CE Marking
Technical files, Design History Files, EU MDR/IVDR submissions, and FDA 510(k)/PMA
Learn more — Technical Documentation & CE Marking
Clinical Affairs
Clinical Evaluation Reports, literature reviews, PMCF planning, and data collection
Learn more — Clinical Affairs
Product Development & Engineering
Feasibility studies, risk management, design validation, and market analysis
Learn more — Product Development & Engineering
Regulatory Strategy & Compliance
Regulatory roadmaps, pathway identification, MDR/IVDR transition, and notified body interaction
Learn more — Regulatory Strategy & Compliance
Quality Management Systems
ISO 13485:2016 design & implementation, FDA QSR, gap analysis, SOPs, and audit readiness
Learn more — Quality Management Systems
M&A Due Diligence
Regulatory compliance audits, documentation reviews, and risk assessment for acquisitions
Learn more — M&A Due Diligence
MDR for Asia & Middle East
NMPA, PMDA, CDSCO, MFDS, SFDA, and MOHAP regulatory transition support
Learn more — MDR for Asia & Middle East
Software Documentation & Cybersecurity
IEC 62304 lifecycle documentation, cybersecurity compliance, and secure development
Learn more — Software Documentation & Cybersecurity
Pharmaceutical Combination Products
Drug-device combination regulatory strategy, PMOA determination, and Notified Body Opinion support
Learn more — Pharmaceutical Combination Products
Packaging & Labeling
EU MDR/FDA labeling compliance, ISO 15223-1 symbols, sterile packaging, and multi-language IFU
Learn more — Packaging & LabelingNot sure where to start? Talk through your challenge
Regulatory research
Start with a question. Explore the sources.
Use our AI research tool to explore regulatory documents, inspect cited sources, and prepare a more focused conversation with your team.
For research and orientation. Project decisions need expert review.
Questions you can explore
Example topics · Open the tool to ask your question
- What belongs in an EU MDR technical file?
- How do I approach UDI registration?
- What documentation does IEC 62304 require?
Ask a question → Inspect sources → Explore further
Why Swiss MPC
A specialist team under one senior lead — the engagement model that sets us apart from large firms and freelancers
Swiss Senior Oversight
Every project is supervised by senior consultants based in Switzerland. No junior staff learning on your project.
Single Point of Contact
One senior consultant orchestrates a specialist team behind the scenes, giving you the breadth of a full team with the clarity of a single relationship — no handoffs, no miscommunication.
Fast Onboarding
Our consultants integrate with your team within 3 days. We get to work quickly so you can meet your deadlines.
Flexible Team Resourcing
Scale from a single consultant to a cross-functional team for full projects or discrete sub-projects. Project-based engagements with defined scope and controlled cost — no FTE overhead.
How We Work
A structured approach to regulatory compliance
Free Discovery Call
We listen to your challenges, understand your device, and assess your regulatory needs.
Gap Analysis
We review your existing documentation and identify compliance gaps against applicable standards.
Project Execution
We assemble a specialist team led by a senior consultant — your single point of contact — to close gaps and prepare submissions alongside your team.
Handover & Support
Complete documentation handover with ongoing support for post-market requirements.
Free Discovery Call
We listen to your challenges, understand your device, and assess your regulatory needs.
Gap Analysis
We review your existing documentation and identify compliance gaps against applicable standards.
Project Execution
We assemble a specialist team led by a senior consultant — your single point of contact — to close gaps and prepare submissions alongside your team.
Handover & Support
Complete documentation handover with ongoing support for post-market requirements.
What Our Clients Say
“The project management provided by Swiss MPC was exceptional. Their team was instrumental in meeting and exceeding our goals.”
Alex
Medical Device Manufacturer
CEO
“Swiss MPC guided us through the entire EU MDR transition with remarkable precision. Their senior consultants identified critical gaps in our technical documentation that we had overlooked, and delivered a clear remediation roadmap that kept us on schedule for recertification.”
Sarah
Orthopedic Device Company
VP Regulatory Affairs
“We engaged Swiss MPC for UDI implementation across our product portfolio. Their structured approach to EUDAMED registration and labeling integration saved us months of internal effort and ensured full compliance ahead of the deadline.”
Thomas
Surgical Instruments Manufacturer
Director of Quality
“Our combination product required navigating both pharmaceutical and medical device regulatory pathways simultaneously. Swiss MPC brought deep expertise in drug-device combinations and managed the Notified Body Opinion process seamlessly, helping us achieve EU approval months ahead of our projected timeline.”
Christine
Pharmaceutical Company
Head of Regulatory Affairs
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