QbD Group
Pieter Smits is a seasoned professional with extensive expertise in project management and medical device software. Currently serving as a Project Governance Lead at QbD since August 2013, Pieter develops and implements project management methodologies aligned with corporate strategies. As a Software as a Medical Device and Medical Device Software Expert, Pieter is well-versed in EU and US regulations, focusing on AI and cybersecurity requirements. Pieter also holds a certification as a Lead Auditor for ISO13485, conducting audits for regulatory compliance in the medical device sector. Prior experience at Pfizer included roles as Project Lead for business intelligence implementation and Project Engineer, where Pieter contributed to the development and compliance of electronic batch records. Pieter holds a Master of Science degree in Bioscience Engineering with a specialization in cell and gene technology from KU Leuven.
QbD Group
The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a multinational company with over 450 high-qualified employees. Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions: • Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle. • Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy. • Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software. • Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities. • Quality Control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products. • Software solutions: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU). • Go to market: We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.