Manufacturers are expected to continuously keep abreast of new laws and regulations in life science & health. Companies that approach regulations integrally are at an advantage in this respect. Moreover, reducing risks and costs by using a good quality system in combination with a regulatory strategy contributes to bringing new products to the market faster.
The development of medical devices involves a lot: not only must the quality of these products be of the highest level, the products must also comply with the many laws, regulations and certifications. Think of CE marking, the Medical Device Regulation (MDR), the FDA and ISO and IEC standards. An integrated approach to all these regulations and standards can speed up the time-to-market of your products, as can a sound risk management approach. Moreover, the establishment of a good quality system that not only describes the correct procedures, but is also properly implemented by employees.