Medical Devices

From electric toothbrushes to implants or combination products – the application of GMP (Good Manufacturing Practices) is also required for the manufacturing of medical devices in classes I, I m,r,s  IIa, IIb, III and for combination products.  While the term “GMP” is not as established here, the underlying topics certainly are.

With the Compliance Consulting Medical Devices range of services, gempex provides targeted and effective consultancy and support throughout the entire life cycle of the medical device – for example, design and development, production management, supplier controls or post-market surveillance.

Practical expertise across industries and current expert knowledge regarding management and regulations are contributed for tailor-made concepts and ongoing support in the development and implementation of quality management systems and during the daily routine.

gempex acts as a quality consultant and is experienced, competent implementation partner for the solution-oriented, efficient realisation of the specific requirements in various product segments.

Select Service Examples*

  • New Combination Products Business Area of a Pharmaceutical Product Manufacturer
    Definition and implementation of a supplier/outsourcing strategy, Q&R training ISO 13485:2016/US FDA QSReg/ISO 14971:2019
  • Medical Device Manufacturer EU MDR Class II/III
    Inspection readiness, audit/inspection support and follow-up, CAPA management, single point of contact for notified body, QMS remediation
  • New Facility for Manufacturing and Packaging Dental Products
    Risk management support and implementation
  • Preparation and Follow-up for an FDA Inspection of a Medical Device Manufacturer
    CAPA processing, introduction of quality assurance measures, risk analyses, qualification, validation, preparation of SOPs

* We will gladly provide you with specific references on request.