Regulatory and Quality Solutions (R&Q) is a provider of regulatory and quality consulting and engineering to medical device companies. From strategy to tactical implementation, R&Q partners with clients by providing balanced solutions and hands-on support that enhance the commercialization and post-market processes for medical devices.
Featured services: EU MDR transition, CERs
- EU MDR transition: R&Q touts its expertise in EU MDR transition. It has expert implementers who are experienced with multinational companies that are transitioning to the EU MDR; validated EU MDR transition process, procedures and tools; tiger team implementation process, with program management minimizing burden on daily client operations and services ranging from portfolio planning support to the transition to MDR technical documentation and a compliant QMS.
- CERs: R&Q has a structured CER business unit with a dedicated team that includes program management and SMEs. It offers full service or just what you need offerings, including plan development, literature search and reviews and report writing (CER, CEP, PMCF). The company also specializes in all clinical specialties and device classifications and has a team that is capable of supporting high volume requests.
Visit R&Q at booth #505 at DeviceTalks Boston.