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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 Medical Device Q&R Compliance 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.