Comprehensive Regulatory and Compliance Solutions for Medical Devices
Fast Track Documentation Implementation service to support your Medical Device, Combination Product and IVD to achieve global regulatory compliance.
Your Partner in Medical Device Regulatory Compliance
Value
Competitive Packages
Team
Single Source Staffing
Speed
Fast Onboarding
Security
Safe Data Handling
Quality
Senior Swiss Consultants oversight
Simplicity
Single point of contact
Reliable & Effective
Navigating the complex regulatory landscape for medical devices in Europe and the US requires precision and informed strategies. Our expert team provides end-to-end support for regulatory compliance, quality management, and market access, ensuring your medical devices meet all necessary standards and regulations.
- Full quality control by Senior Consultants in Switzerland
- Single point of contact for streamlined project management
- Professionals with proven track records
- Fully remote or on site presence options available
Leaders in Medical Compliance
We are leaders in medical compliance, guiding companies through EU MDR, IVDR, CE Marking, and FDA pathways with precision. Our services include ISO 13485:2016 QMS design, feasibility studies, clinical evaluation reports (CER), UDI setup, and technical file preparation. With expertise in gap analysis, documentation, data collection, and training, we ensure compliance, smooth approvals, and faster market readiness.
Our Clients
What we do: Compliance Solutions
Unique Device Identification (UDI)
Definition, setup, labeling integration, EUDAMED & GUDID submissions, and direct/laser marking for full traceability.
Technical Documentation & CE Marking
Technical file preparation, Device Master Records (DMRs), EU MDR/IVDR submissions, FDA 510(k)/PMA support, and change control documentation.
Clinical Affairs
Clinical Evaluation Reports (CERs), literature reviews, data collection, and Post-Market Clinical Follow-up (PMCF) planning.
Product Development & Engineering
Feasibility studies, market analysis, risk management, and design validation for innovative devices.
Quality Management Systems (QMS)
ISO 13485:2016 design & implementation, FDA QSR (21 CFR Part 820) compliance, gap analysis, SOPs, audits, and staff training.
Regulatory Strategy & Compliance
Tailored regulatory roadmaps, FDA & EU pathway identification, MDR/IVDR transition guidance, and notified body interaction.
M&A Due Diligence
Regulatory compliance audits, documentation reviews, and risk assessment for medical device mergers and acquisitions.
MDR for Asia & Middle East
Transition support from NMPA, PMDA, CDSCO, MFDS, SFDA, and MOHAP to full EU MDR compliance, including technical file remediation and AI-powered compliance tools.
Swiss MPC delivers comprehensive medical device regulatory and compliance solutions, covering EU MDR, IVDR, CE Marking, FDA pathways, ISO 13485 QMS, UDI, technical documentation, CERs, and regulatory strategy.
Yes. Our “Fast Track Documentation Implementation” service and proven track record mean we consistently achieve 100% success in helping devices meet global regulatory requirements.
We support clients worldwide with expertise in European MDR/IVDR, US FDA pathways (510(k), PMA, De Novo), and regional frameworks across Asia and the Middle East (NMPA, PMDA, CDSCO, MFDS, SFDA, MOHAP).
We provide fast onboarding — within 3 working days — ensuring your compliance journey begins without delay.
Our clients benefit from single-source staffing, Swiss senior consultant oversight, 200+ years of combined expertise, competitive packages, and flexible remote or on-site collaboration.
Yes. We manage technical file preparation, Device Master Records (DMRs), and support FDA pathways (510(k), PMA, De Novo), ensuring smooth approvals in both Europe and the US.
Absolutely. We provide literature reviews, data collection, drafting, and submission of CERs in compliance with EU MDR and MEDDEV 2.7/1 Rev 4.
Yes. We design and implement ISO 13485:2016 QMS, conduct gap analyses, prepare documentation, and deliver training to align with both EU and FDA QSR requirements.
Yes. We specialize in MDR transition for Asian and Middle Eastern manufacturers, bridging regulatory gaps, remediating documentation, and ensuring EU-ready compliance.