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.