[acronyms as QP (Qualified Person) and or CO (Compliance Officer) and or LP (Legal Person)]
As recognised independent professional service provider we’ve developed
(A) QP or CO services for SME organizations or manufacturers; and
(B) QP or CO Training Program.
Our ‘Person for Regulatory Compliance’ holds an university degree in required scientific discipline; has an official BIG-registration at the Dutch Inspectorate of the Ministry of Health; has approximate twenty years experiences in the field of medical technology and life sciences; has approximate fifth teen years’ his IRCA - COQ registration as third party auditor; etc.
SME manufactures are not be required to have the person responsible for regulatory compliance within their organization but shall have such person permanently and continuously at their disposal [MDR: Article 15(2)].
Ad A. MRM as QP and or CO Service Provider
As recognized professional service provider in the European Union (EU) we offer Qualified Person (QP) and or Compliance Officer (CO) support services to assist your company with
- Medical devices under the MDR and or IVDR;
- Investigational Medical Device’s;
- Medicinal Products (API)’s;
- Medicinal Investigational Products (IMPs) to comply with GMP requirements.
As QP service provider we support you to ensure that i.e.:
- Adequate conformity route is adopted in accordance with the quality management system;
- technical documentation (technical file, DHF, DMF) is up-to-date;
- Declaration of Conformity (DoC) is drawn up;
- Post Marketing surveillance obligations (i.e. PMS, vigilance, PMCF) are compiled in accordance with the legal framework;
- Reporting obligation are fulfilled;
- Drawn up required Statement as needed for investigational devices
Ad B. Qualified Person (‘Person Responsible for Regulatory Compliance’) Training Program
One key topic within the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) is for a “Person Responsible for Regulatory Compliance” to be employed by Manufacturers. The MDR / IVDR regulation includes qualifications and experience required for this role as well as what this person (or people) will be responsible for.
Manufacturer must ensure that their QP / CO does have a good theoretical and practical knowledge of the regulations, covering the whole area rather than just relying on that they have picked up ‘on the job’.
MRM has a program of education for today's quality and regulatory affairs professional. If you want to improve your competence, enrol in our flexible quality and regulatory modules:
- Module 1 - EU Regulatory Frameworks
- Module 2 - EU Medical Device Design and Risk Management
- Module 3 - Clinical Evaluation for Medical Devices
- Module 4 - Developing and Maintaining Technical Documentation
- Module 5 - Quality Management Systems for Medical Devices
- Module 6 - Post-Market Surveillance and Vigilance for Medical Devices
- Module 7 - Working with EU Regulatory Stakeholders as Part of the EU Conformity Assessment Process
Who Should Enrol?
- Industry professionals representing product developers, manufacturers, distributors, service providers, entrepreneurs, investors and regulators dealing with medical device products,
- Whose work responsibilities include the preparation and management of medical device pre- and post-marketing submissions to Competent Authorities
- Who prepare regulatory submissions to Competent Authorities and or Notified Bodies
- Engineering or life sciences graduates in the early stages of their regulatory careers.
- Professionals working for regulatory agencies