Access to most medical device markets is only possible after proving compliance with specific regulations. Still, most medical device manufacturers ensure compliance the classical way with bulky quality systems, lots of records and a large quality and regulatory staff.
The current market however requires flexible, adaptive companies. Grey RA advocates ‘lean compliance’ where principles borrowed from lean manufacturing are used to reduce and simplify processes and documentation.
Over the last years, Grey RA has helped several medical device manufacturers to become more lean. Interested in the Grey RA approach? Contact Grey RA today for a free introduction in the possibilities.