Regulatory Mark
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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
How Many Employees Does This Company Have?
2
Which Industry Does This Company Belong To?
medical devices
What Is the Annual Income?
What Is the Technology of All the Company’s Website?
Gmail, Google Apps, Amazon AWS, Amadesa, Google Font API, Ubuntu, Woo Commerce, Mobile Friendly, WordPress.org, Apache, reCAPTCHA
What Year Was the Company Founded?
2016
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