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.