Roberts Consulting & Engineering
Roberts Consulting Engineering (RCE) is a specialized consultancy based in Encinitas, CA, providing expert services in medical device and in vitro diagnostic consulting. The company offers a wide range of services, including ISO 13485 and ISO 9001 implementation and training, CE marking, design dossiers, and 510(k) submissions, catering to organizations from small startups to large Fortune 500 companies.
With a team of experienced associates who have worked with leading device companies, notified bodies, and ISO registrars, RCE combines industry knowledge with a commitment to quality and compliance. They also provide additional support in areas such as sterilization, biocompatibility, Canadian device licenses, and supplier audits.
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