Regulatory Mark is a regulatory, quality, and clinical affairs consulting group located in Cincinnati OH, USA. We provide medical technology companies and entrepreneurs with expert guidance and practical solutions for compliance with domestic and international regulations pertaining to their medical devices. Our regulatory solutions fit with your business needs. Areas of expertise include ISO 13485 and 14971, FDA 21 CFR 807 (establishment and listing), 803 (MDR), 812 (IDE), 820 (QSR) and 1040 (laser products), MDD 93/42/EEC, MDR 2017/745, cybersecurity, Software as a Medical Device (SAMD), mobile medical apps (MMA), MDSAP, and CMDCAS.
Our special interest is finding solutions to get novel technology to market as quickly as possible. We focus on regulatory so you can focus on business.
Company’s Keywords:
regulatory affairs, quality assurance, clinical trials, medical technology, medical device regulation, medical devices, fda, compliance, quality system regulation, quality management system, iso 13485, mdr 2017, 745, design controls, 510, international regulatory registrations, cybersecurity, connected devices, mobile medical apps, pmcf, clinical evaluation reports
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