Swiss Precision. Global Compliance.
Swiss Precision for Medical Device Compliance
Senior-led regulatory consulting for medical devices and combination products — EU MDR, FDA, and global market access
Trusted by leading medical device and pharmaceutical industry leaders
0+
200+ years combined expertise
0%
100% compliance success rate
0
3-day onboarding
0+
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
What sets us apart from large consulting firms and freelance consultants
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 dedicated consultant manages your project from start to finish. 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.
Competitive Packages
Senior-level expertise at competitive rates. We deliver premium quality without the overhead of large consulting firms.
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
Our senior consultants work alongside your team to close gaps and prepare submissions.
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
Our senior consultants work alongside your team to close gaps and prepare submissions.
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
CEO, Medical Device Manufacturer
“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
VP Regulatory Affairs, Orthopedic Device Company
“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
Director of Quality, Surgical Instruments Manufacturer
“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
Head of Regulatory Affairs, Pharmaceutical Company
Why Manufacturers Choose Swiss MPC
The right balance of expertise, speed, and value
Swiss MPC
Our Approach- Senior Swiss consultants on every project
- Single dedicated point of contact
- Onboarding within 3 working days
- Competitive pricing without agency overhead
- Remote and on-site flexibility
- 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 engagement models
- Variable quality across consultants
Freelance Consultants
- Single expert, limited breadth
- No backup if consultant unavailable
- Availability constraints
- Lower pricing but limited scope
- No quality assurance oversight
- No structured project management
Ready to Accelerate Your Regulatory Compliance?
Schedule a free consultation with our senior regulatory experts
