Certified Compliance Solutions

medical devices

About

A recognized industry leader for over 20 years in regulatory and quality compliance for medical devices, pharmaceuticals, and biotech. We have assisted over 200 clients in meeting QSR and FDA compliance. We guarantee our work relative to FDA regulations and ISO standards. Our training is referenced in FDA's software validation guidelines. We are your full service solution to quality management, design control, software validation, and software development. We provide support from custom medical device development to independent testing and 510(k) submission services. Our company has been hired by the FDA Head-quarters to provide software training for FDA investigators! Our experience and expertise ensure that you not only receive quality services but also full compliance with current FDA and European Community regulations. We take the mystery out of regulatory requirements for medical devices.

Technologies

Gmail Google Apps WordPress.org Mobile Friendly Bootstrap Framework Apache Google Tag Manager Android Remote AI

Keywords

cybersecurity fda part 11 validation iso medical device testing medical equipment manufacturing medical device consulting fda submissions fda inspection support software process assessment standards safety risk analysis eu mdr compliance iso audit support mdsap audits b2b manufacturing product development 510(k) submission support quality system implementation post-market surveillance healthcare government design controls documentation iso 13485 ce mark technical files risk assessment regulatory training testing laboratories and services

Location

11665 Avena Pl, San Diego, California, United States, 92128-2421

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