SMESTAD & ASSOCIATES

Smestad & Associates LLC offer services to support FDA and EU regulatory and compliance needs for medical device companies. We supply reliable, on-target and practical solutions throughout medical device design and development and post-approval phases including regulatory submissions, regulatory compliance and quality. Smestad & Associates LLC can help guide you to meet the requirements of QSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, Medical Device Regulation, Medical Device Directive, Japanese Pharmaceutical Affairs Law (JPAL) and Canadian Medical Devices Regulations (SOR/98-282).

Also known as: Smestad & Associates LLC