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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

info@swissmpc.com

Trusted by leading medical device and pharmaceutical industry leaders

Zimmer Biomet
CSL Behring
Johnson & Johnson
Ovation Medical
Novartis
Limoss
Mathys Medical

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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

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

01

Free Discovery Call

We listen to your challenges, understand your device, and assess your regulatory needs.

02

Gap Analysis

We review your existing documentation and identify compliance gaps against applicable standards.

03

Project Execution

Our senior consultants work alongside your team to close gaps and prepare submissions.

04

Handover & Support

Complete documentation handover with ongoing support for post-market requirements.

AI-Powered

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What Our Clients Say

The project management provided by Swiss MPC was exceptional. Their team was instrumental in meeting and exceeding our goals.
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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.
S

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.
T

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.
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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

info@swissmpc.com