From wound plasters to implants or combination products – the application of the principles 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 efficient consultancy and support throughout the entire life cycle of the medical device – for example, design and development, risk management, validation and verification of production and product or post-market surveillance.
Practical expertise across industries and current expert knowledge regarding regulations are brought in to provide tailor-made concepts and ongoing support in the development and implementation of quality management systems and processes for quality assurance. Also in such as the control of suppliers or the validation of computer-based systems.
gempex acts as a quality consultant and is experienced, competent implementation partner for the solution-oriented, efficient realization of the specific requirements in various product segments.