Services & Expertises

Our consultancy services focus on support of the medical device industry, supply and distribution chain, the software development community and healthcare institutes.

We:

  1. Have specific experience with and knowledge about a broad range of medical devices, processes and technical subjects (e.g. software devices, process (software) validation, risk management, biocompatibility, clinical writing).
  2. Have knowledge about and experience with the implementation of MD regulatory and standards requirements for a wide variety of products and organizations.
  3. Transfer our knowledge and expertise towards your team, train your team on the job.
  4. Use a phase in/phase out principle: we adjust our involvement during the course of the project according to your needs.
  5. Ensure  that we will keeping an overview of compliance-actions needed, can assist with setting priorities and project management.
  6. Have extensive work experience in the team at the various stakeholder (roles): we adjust to the specific stakeholder position in the MD field.
  7. Can fulfill adjustable roles: coaching/teaching/sparring/project management/expert in several technical areas/auditor-reviewer in the organization.
  8. Provide consultants that are experienced to work in organizations at various stages and sizes (start-up to multinationals). They assist growing or shifting organizations with the establishment of a (new) internal structure e.g. (re)defining process flows, roles and responsibilities.
  9. Provide you with access to experiences and expertises in the MDProject team.

 

In short: we will help you to meet the regulatory requirements in a practical way.

The following services are provided.

 

Quality management system:

  • Implementation of ISO 13485:2016 compliant Quality management system.
  • Integration of regulatory requirements in your Quality management system, for example the requirements in the EU MDR/IVDR and of the FDA (21 CFR Part 820).
  • Include the requirements of MDSAP (medical device single audit program) in your Quality management system.
  • Perform gap analysis towards Quality management system requirements,
    set-up and execute actions plans.
  • Perform internal audit on your Quality management system.
  • Facilitate management reviews.
  • Facilitate contacts with certification and regulatory bodies.
  • Assist during audits of certification and regulatory bodies.

 

Technical support:

MDProject consultants help you with implementation of all relevant processes in your organization. A selection of processes is identified below:

  • Design control processes, resulting in design history files / Design and development files
  • Implement production control processes, resulting in traceable products, including proper identification, using validated processes (including software validation)
  • Developing regulatory strategies
  • Risk management (ISO 14971)
  • Clinical Evaluation (MEDDEV 2.7.1 rev04 and EU MDR)
  • PMS and PMCF (EU MDR)
  • Biological Safety Evaluations (ISO 10993 series)
  • Electrical Safety and EMC test evaluations (IEC 60601 series)
  • Software development (IEC 62304)
  • Useability Engineering (IEC 62366)
  • Product standards (harmonized / recognized by authorities)
  • Regulatory filing

As a result of this support, technical documentation that meets the requirements of the different standards and regulations is created, either by MDProject consultants or with input from MDProject consultants.

 

For hospitals, we help to implement the requirements of the new EU MDR and IVDR in your existing processes, to ensure that per May 26, 2020 you are compliant. Training of your staff on the requirements and impact is available through our trainingen.