DE | EN
 

Regulatory & QM OUTSOURCING

Vorlesen
 

Let us do the work.

The accelerated approval of your medical device in your selected target markets provides not only for a competitive advantage, but is also a guarantee for growth and profit. Outsourcing means we can relieve your organization of regulatory affairs, quality management, project management leaving you to focus on your core competencies. Herewith an overview of activities that we are happy to take on:

Regulatory Affairs

  • Compile and edit the technical documentation for CE
  • Compile and edit the technical documentation for international approvals
  • Manage the complete national or international approval of your medical device
  • Research applicable national and international regulations, standards and guidelines
  • Preparation of declarations of conformity
  • Assessment of your existing technical documentation based on current valid regulatory requirements (GAP analysis)
  • Compile a 510(k) submission for medical device approval in the United States
  • Classification of medical devices taking into account intended purpose, indications and marketing area
  • Create checklist to meet the Essential Requirements of European Directive 93/42/EEC
  • Create checklist to meet the General Safety and Performance Requirements according to Regulation (EU) 2017/745 (MDR)
  • Conduct Clinical Evaluation according to MEDDEV 2.7-1 Rev 4.
  • Conduct Clinical Evaluation according to MDR (European Regulation 2017/745)
  • Write a Clinical Evaluation Report according to international regulatory requirements

Quality Management

  • Conduct internal audits according to the following Regulations and Standards:
    • EN ISO 13485:2016/AC2016
    • ISO 13485:2016
    • European Directive 93/42/EEC
    • Regulation (EU) 2017/745 (MDR)
    • German Medical Devices Act
    • German Regulations
    • 21CFR820 (Quality System Regulation)
    • MDSAP (Medical Device Single Audit Program)
  • Adoption of the function of "Executive Management" (quality management representative)
  • Conducting internal training
  • Assessment of the existing quality management system based on current valid regulatory requirements (GAP analysis)
  • Develop process and procedure instructions (SOP)

Project Management

  • Implement a quality management system according to ISO 13485/EN ISO 13485
  • Implement a quality management system according to 21CFR820
  • Implement a quality management system according to MDSAP (USA, Canada, Brazil, Australia, Japan)
  • Implement sub-processes (e.g. development, post-market surveillance, etc.)
  • Moderate design reviews (development reviews)
  • Moderate management reviews (management reviews)
  • Implement a new documentation system

Please feel free to contact us. We will gladly provide competent and individual advice.

top