evo820

We are excited to announce the launch of our eQMS, a subscription online document platform for your Quality Management System (QMS). Led by a respected and highly knowledgeable industry professional, evo820 takes the headache and confusion out of the FDA’s 21 CFR 820 guidance and 510(k) Submissions. Tim has a diverse experience with the medical device manufacturing, materials, management, and regulatory affairs spanning 45 years. Tim has engaged in the development of 9 medical device systems through design, production, and their regulatory processes. With the years of business experience that we bring to your project, evo820 provides trusted guidance for your Regulatory Affairs or Quality Assurance project that leads us to a successful conclusion. We understand the FDA requirements and provide clear guidance, training and document management that keeps you in regulatory agency compliance.