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Alex Laan, BSc, Dipl.-Ing

Principal Regulatory Consultant, IVD

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Alex possesses wide-ranging expertise with IVD manufacturers in the areas of quality and regulatory strategy. Mr. Laan spent 12 years at Notified Body, DEKRA, where he served in various positions ranging from Dossier Reviewer to Lead Notified Body Auditor and Certification Manager. Alex, ultimately appointed as the head of the Certification Management Team for DEKRA, oversaw IVD and high-risk medical devices, including implants and animal tissue R&D products.

Alex, joining NAMSA in 2018, has been an integral part of the team, working with multiple IVD manufacturers to assist them in gaining EU and U.S. regulatory approval and clearance.

CORE COMPETENCIES

  • Developed 2 ELISA-based IVDs, from R&D stage to production stage
  • Developed an ISO 13485 and IVD Directive-based Quality Management System (QMS) for a start-up IVD company. Mr. Laan provided regulatory support for EU (CE Certification) and U.S. FDA 510K approval for ToRCH products, consisting of 15 IVD devices (covering Annex II List B IVDD in a period of 4 years).
  • Leading audit teams at various global IVD and medical device companies, ranging from start-up to multinational organizations; Alex assisted in auditing against ISO 13485 requirements, IVD Directive 98/79/EC, IVD Regulation EU 2017/746, MDD 93/42/EC and MDSAP
  • Serving in technical and senior positions at DEKRA and ultimately being responsible for all medical device and IVD device certification decisions worldwide
  • Reporting as first point of contact with the EMA, Dutch Ministry of Health and Medical Device Inspectorate and IGJ regarding IVD and medical device technical Notified Body matters
  • Overseeing gap analysis of regulatory and clinical strategies, submissions and key documents pertaining to IVDD and IVDR
  • Design dossier and technical file preparation, including preparation/input into key documents essential requirements/GSPR checklists, risk management documentation, study reports and performance evaluation documentation
  • Expertise in interpretation and implementation of MDCG guidance documents
  • Training, inclusive of CE marking requirements such as IVDR, development of training materials and dedicated presentations for IVD manufacturers (seminars, webinars and client groups)
  • Serves as Co-Chair of the RAPS EU Convergence Conference for both medical device and IVD tracks

RECENT PROJECTS

  • IVDR transition project at two multinational IVD manufacturers, addressing weaknesses in technical documentation and development of QMS, technical and clinical strategy
  • Successful application for COVID-19 molecular biology assay with the FDA under EUA requirements
  • Effectively implemented IVDR requirements for QMS with U.S.-based IVD scale-up manufacturer