Market Access for Medical Devices and Software

VDE MeSo offers practical support for the approval and certification of medical devices and software. We help you to bring your product to market faster and more efficiently.

Do you have a question?
We can answer many of your questions easily and quickly on the phone.
Please give us a call: +49 69 6308 367

Our expertise:

Regulatory Affairs

Depending on the economic area, manufacturers must meet different legal requirements if they want to market a medical device. We support you in the approval process:

  • (risk) classification of the product
  • compilation of approval requirements
  • development of an approval strategy
  • communication with Notified Bodies, FDA and other organizations
  • approval in Europe (conformity assessment and CE marking)
  • approval in the US (510 (k), PMA)
  • approval in other economic areas

Quality Management

A functioning quality management system is a prerequisite for the approval of medical devices. We implement for you what is efficient and necessary:

  • establishment of a quality management system according to ISO 13485:2016
  • adaptation to 21 CFR 820 QSR or other standards as required
  • gap analyses
  • support during certification

Risk Management

The use of medical devices is potentially dangerous for patients and users. Manufacturers must therefore carry out a risk management process. We support you in this:

  • development of a risk management process according to ISO 14971
  • development of a risk management plan
  • definition of risk acceptance criteria
  • conduction of hazard and risk analyses
  • systematical assessment of risks
  • implementation of risk minimization and market monitoring

Usability Engineering

The usability of medical devices has become increasingly important. We help you to optimize your product and to document the results:

  • development of a usability engineering process according to IEC 62366-1
  • documentation of usability requirements according to FDA specifications
  • use and requirement analyses
  • user interface design
  • usability evaluations

Medical Software

Software can be device-independent like a medical app or be part of a medical device. The regulatory requirements have increased considerably. We will show you how to bring your software to market faster:

  • implementation of software lifecycle process (IEC 62304, IEC 82304-1, IEC 60601-1 and FDA guidelines)
  • requirement management for software
  • linking (agile) software development with documentation requirements
  • implementation of special safety and cybersecurity requirements
  • approval of products with artificial intelligence applications (AI)

Clinical Affairs

Manufacturers must use clinical data to check whether their product is safe and does what it is supposed to do. We recommend starting the clinical evaluation as early as possible. We support you in this:

  • generation of clinical data through systematic analysis of different sources
  • preclinical evaluation
  • planning, conducting and documentation of clinical evaluations
  • clinical gap analysis
  • planning, conducting and documentation of clinical trials

Post-Market-Surveillance

Manufacturers are legally obliged to monitor whether the safety and performance of their medical devices are guaranteed after they have been placed on the market (PMS, Post-Market-Surveillance). This includes clinical evaluation (PMCF, Post-Market-Clinical-Follow-Up). Our PMS and PMCF service:

  • structuring PMS or PMCF processes
  • gap analysis with relation to the benefit/risk ratio
  • creating PMS/PMCF plans
  • collection and evaluation of data
  • planning and conduction of clinical PMCF studies
  • PMS documentation and reports

Technical Documentation

Manufacturers of medical devices are subject to extensive documentation obligations. The structure of the documentation varies depending on legal or normative requirements. We support you in creating the relevant files:

  • STED (Summary Technical Documentation)
  • medical device file
  • DHF (Design History File)
  • DMR (Device Master Record)
  • DHR (Device History Record)
  • linking technical documentation and quality management