Complete Medical Device Compliance with 100% Success Rate
Fast Track Documentation Implementation service to support your Medical Device, Combination Product and IVD to achieve global regulatory compliance.
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
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.
Our Clients
Successful completion of Regulatory Projects with a diverse global client base.
Why Swiss MPC
Competitive Packages
Competitive affordable rates
Single Source Staffing
All required consultants from one provider (remote options)
Fast Onboarding
Onboarding within 3 working days
Safe Data Handling
Encrypted online storage management solution
global top consultants
 Full quality control by Senior Consultants in Switzerland.
Single point of contact for streamlined project management & accountability assurance.
Full transparency and the best quality solutions utilising Swiss based Biomedical Engineering Professionals with proven track records
None of the difficulties of hiring and managing individual consultants
Fully remote or on site presence options available
Achieve CE Marking with Comprehensive Technical File Preparation
Setting up a comprehensive technical file is critical for achieving CE Marking for your medical devices.
We provide end-to-end support for technical file preparation, ensuring regulatory compliance and a smooth submission process.
Regulations:
- EU MDR
- In Vitro Diagnostic Regulation (IVDR)
Services:
- Documentation compilation
- Technical file submission
- Regulatory compliance checks
Regulations:
- FDA UDI Rule
- EU MDR UDI requirements
Services:
- UDI data element definition
- Database setup
- Compliance checks
Accurate Definition and Setup of UDI Data Elements
Accurate definition and setup of Unique Device Identification (UDI) data elements are essential for regulatory compliance.
We provide expert guidance on UDI requirements, ensuring your devices meet all regulatory standards.
Comprehensive Clinical Evaluation Report (CER) Preparation
Preparing a comprehensive Clinical Evaluation Report (CER) is essential for regulatory submissions.
We offer expert support in developing CERs to meet regulatory requirements, ensuring your submissions are detailed and compliant.
Standards:
- EU MDR
- MEDDEV 2.7/1 Rev 4
Services:
- Clinical data collection
- Literature review
- CER drafting and submission
Services:
- Market research
- Feasibility study reports
- Cost-benefit analyses
Informed Feasibility Studies and Market Analysis
Thorough feasibility studies and market analysis are essential for the commercial success of your medical devices.
We provide comprehensive support to evaluate the technical and commercial viability of your product concepts.
Robust ISO 13485:2016 System Design and Implementation
Implementing a quality management system (QMS) in accordance with ISO 13485:2016 is crucial for ensuring product quality and regulatory compliance.
We offer comprehensive support for QMS design and implementation.
Standards:
- ISO 13485:2016
Services:
- Gap analysis
- QMS documentation
- Staff training and support
Europe:
- Medical Device Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)
- CE Marking requirements
US:
- FDA regulatory pathways
- 510(k) premarket notification
- De Novo classification
- Premarket Approval (PMA)
Expert Regulatory Pathway Identification for Europe and the US
Navigating the complex regulatory landscape for medical devices in Europe and the US requires precision and informed strategies.
Our team specializes in identifying the most efficient regulatory pathways to ensure compliance and market readiness.
Fast Track MDR. Guaranteed.
Request More Information
- Receive our detailed case studies in a PDF
- Receive our Team and Founder credentials
- Understand if Swiss MPC would be a right fit for your project or not