SwissPrecisionforMedicalDeviceCompliance
Specialist consultant teams led by senior Swiss experts — flexible, project-based regulatory resourcing for EU MDR, FDA, and global market access
Trusted by leading medical device and pharmaceutical industry leaders
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200+ years combined expertise
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100% compliance success rate
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3-day onboarding
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Devices brought to market
Comprehensive Regulatory & Compliance Solutions
From concept to market, we guide your medical devices and combination products through the global regulatory landscape
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.
Ask Our Custom AI for Advice on Your Project
Search 750+ regulatory documents covering EU MDR, FDA pathways, IEC 62304, and more — with AI-powered analysis. Free and instant.
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
Why Manufacturers Choose Swiss MPC
A specialist team under one senior lead — without large-firm overhead or solo-consultant risk
Swiss MPC
Our Approach- Senior Swiss consultant leading every project
- Single contact orchestrating a specialist team
- Onboarding within 3 working days
- Project-based engagements, no FTE overhead
- Scales for full projects or sub-projects
- 100% compliance success rate
Large Consulting Firms
- Junior staff assigned to your project
- Multiple handoffs between teams
- Weeks of onboarding bureaucracy
- Premium pricing for brand name
- Rigid retainers and FTE commitments
- Variable quality across consultants
Freelance Consultants
- Single expert, limited breadth
- No backup if consultant unavailable
- Availability and capacity constraints
- No cross-functional team coverage
- No quality assurance oversight
- No structured project management
Ready to Accelerate Your Regulatory Compliance?
Schedule a free consultation with our senior regulatory experts
Typically responds within 24 hours