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Course on Medical Device Safety Requirements:
IEC 60601-1 3rd EDITION
Are you ready? Canada and Europe are requiring compliance with the 3rd edition by 1 June 2012. The US FDA is requiring compliance by 30 Jun 2013. The objective of this course is to highlight the important aspects of the standard and to give you an overview of the main changes compared to the 2nd edition.
Date: 11th of March, 2011
Location: Rantasipi Airport Congress Center, Robert Huberin tie 4, 01510 Vantaa
The IEC 60601 Part 1 general standard serves as the foundation for the international electrical medical equipment series of safety standards. The series includes horizontal collateral standards, IEC 60601-1-xx, for specific equipment technologies or other general issues; and vertical particular standards, IEC 60601-2-xx, for specific types of medical equipment. The series forms the basis for the consensus safety standards for most markets in the world, including, US, Europe, Japan, Canada, Australia, China, Korea, Brazil, and Argentina.
Agenda
| 08.30 | Registration and coffee |
| 09.00 | Introduction |
| 09.15 | The big picture, definitions, basic safety, essential performance Risk management |
| 10.15 | Break |
| 10.30 | Marking, ID and documents Electrical hazards |
| 12.00 | Lunch |
| 13.00 | Thermal and other hazards Mechanical hazards Radiation / Accuracy / Testing medical electrical equipment PEMS, Programmable Electrical Medical Systems |
| 14.45 | Break |
| 15.00 | EMC, Electromagnetic Compatibility |
| 16.30 | Summary, Q&A |
| 17.00 | FiHTA Happy Hour Networking |
| 18.00 | Adjourn |
Course instructor: Mikael Dahlke has more than 25 years experience in software and systems engineering, with 15 years working for a leading medical device manufacturer.
He has worked many years as a system architect for advanced electro medical devices. A key competence is risk management, he introduced a process and was responsible for performing risk analyses in several development projects. Regulatory experience includes implementing a quality system according to medical device directive and extensive experience from FDA audits.
Mikael has 8 years experience from requirements management for very large systems. This included using efficient methods for prioritizing requirements. Current experience includes implementation of ISO 13485 and ISO 62304 at a small medical device company.
Course fee: 500€/350€* (* FiHTA member companies). VAT 23% shall be added to the fee. The fee includes: lectures, course materials, coffee and lunch as well as the book that follows the requirements of the 3rd Edition: EU:n lääkintälaitedirektiivin mukaisten terveydenhuollon tuotteiden suunnittelu ja valmistus viranomaisvaatimukset huomioiden, Ilpo Pöyhönen & Kaarle Kylmälä, VTT.
Registration: Submit the registration form by February 25th, 2011.
Cancellation policy: Cancellation of registration prior to the commencement of the event: 7 days or less, 50 %. If no cancellation, full fee.
For more information: terhi.kajaste@teknologiateollisuus.fi , tel: +358 50 576 5536
Rights to changes reserved.
Wellcome!
