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.

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

Find out about our Founders, Project Managers and Senior & Junior Consultants with a combined 200 years of regulatory experience.
See our Team

Our Clients

Successful completion of Regulatory Projects with a diverse global client base.

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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.

  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)
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Services:
  • Documentation compilation
  • Technical file submission
  • Regulatory compliance checks
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.

Regulations:
  • FDA UDI Rule
  • EU MDR UDI requirements
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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
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Services:
  • Clinical data collection
  • Literature review
  • CER drafting and submission

Global top consultants

Find out about our Founders, Project Managers and Senior & Junior Consultants with a combined 200 years of regulatory experience.
See our Team
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.

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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.

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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.

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Fast Track MDR. Guaranteed.

The new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of the Medical Device Regulation. Swiss MPC’s Fast Track MDR service can support your product transition to the new regulation by completing an assessment against key MDR changes
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Step 1 - Gap Analysis

Gap Analysis of your product file to determine the complexity and effort required

Step 2 - Effort & Time Estimate

Generation of a project cost & time estimate so our clients can budget and plan accordingly

Step 3 - Implementation & Handover

Project implementation according to agreed deliverables and handover after successful completion

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  • 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