Standards, Harmonisation Process and Common Specifications

Standards, Harmonisation Process and Common Specifications

Course Time 29 Min
Lessons 1 Lesson
Price
$75 Per person

Lecturer

Nils-Åke Lindberg
Nils-Åke Lindberg
Member of the Board, EAAR; CEO, QAdvis, Sweden
Nils-Åke has more than 35 years of experience in the medical device industry. He is based in Sweden as the CEO of QAdvis providing regulatory consultancy support and authorised representation to clients globally. He has deep international management experience of quality assurance and regulatory affairs as well as senior management positions within international Operations. Having also lived in the Middle East and the Far East he strives to explain and bridge different and sometimes cultural perspectives in the interpretation of standards and regulatory requirements.

Nils-Åke holds a Master of Science Electrical Engineering from Lund University. He is an active member of standard committee ISO TC210 for quality management system aspects, e.g. ISO 13485. Board member of EAAR and an active stakeholder member of EU COM MDCG working group for Standards.

Description

An overview with background and status regarding the harmonisation process of standards in support of MDR 2017/745 and IVDR 2017/746.

The presentation includes an elaboration on the purpose and benefit of harmonised standards in the European context. Status and ongoing work program in MDCG Subgroup Standards will be discussed.

Status on Common Specifications and planned publications.

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