Pascal Werner Email & Phone Number

Offering consulting, audits, and trainings on medical device certification and data privacy/security, especially for software devices with focus on: - MDR (2017/745) class I/IIa/IIb SaMD/digital health devices - DiGAV/DiGA - Clinical evaluations - Risk management - ISO 13485 (with ISO 14971, IEC 62304, IEC 62366-1, ISO 81001-5-1 etc) - Integrated Management System (e.g. with ISO 27001) - Clinical studies/investigations (MDR, MPDG, ISO 14155) - Use of Confluence and Jira for QMS/IMS and TD in conjunction with tools that are in use for software development anyways, e.g. Github - Fractional chief regulatory officer/PRRCIn the last years I enjoyed working on the intersection of business, engineering, and legal (data privacy/GDPR and medical device certification). Having written privacy policies but also backend code (node.js, mongodb, Docker) together with a distinct business mindset helps a lot to navigate regulatory topics.

Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors are deeply experienced medical device developers and manufacturers who provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments.Prodct creates bespoke development, risk management, manufacturing, and quality strategies aligned with 21 CFR part 820, ISO 13485:2016, IEC 62304:2006, and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary.

Boston, Ma, Us

Berlin, Berlin, De

- data privacy (GDPR compliance)- medical device certification- backend ops & development- project management- technical sales

Frankfurt Am Main, Hessen, De

Espoo, Espoo, Fi

Master Of Science (M.Sc.), Biomedical Engineering

Master Of Engineering (M.Eng.), Biomedical Engineering