KeyMedic offers Regulatory Affairs, Quality Management System and Compliance expertise to the medical device industry, supporting entrepreneurs, startups and manufacturers throughout the product life-cycle.
We believe that each company and each product are unique, and with our knowledge, experience and “think outside the box” approach, we can tailor flexible solutions that will meet both your needs and capabilities, and the regulations.
Regulatory
Regulatory strategy development, preparation for pre-submissions, compilation of dossiers and submissions and license maintenance, in the EU, USA, Canada and more.
Quality
Establishment of a Quality Management System (ISO 13485 / FDA Quality System Regulations / MDSAP), preparation for inspections, on-site quality system audits and supplier audits.
Compliance
Compliance programs, post-market surveillance, risk management, customized training, audits, etc.
Design, development and marketing company with more than 16 years of experience that delivers fantastic results on time and within a budget.
Parente Studio is dedicated to serving the creative needs of any company or product, is passionate about its clients' success and is willing to go the extra mile to ensure ultimate satisfaction and results.
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