Software for medical devices
30 November 2006 / Copenhagen / Denmark
Regulators are worried about software in medical devices. Software often implements basic safety or essential performance, but has a poor record of dependability. IEC 60601-1 3rd edition has a brief clause on Programmable
Electrical/Electronic Medical Systems (PEMS) but lacks details. IEC 62304 is more detailed. It requires a set of processes which can be scaled according to the severity of harm that could arise from a failure of the software.
The standard has been developed in collaboration with the US FDA. Using software processes compliant to IEC 62304, manufacturers can expect to address the requirements of both the EU and the USA as well as many other countries.
Agenda 30th of November
8.30–9.00 Registration, Coffee and Sandwich
9.00–10.15 FDA requirements for SW –Connie Bundy
10.15–10.45 Coffee break
10.45–12.00 FDA requirements for SW continue
12.00–13.00 Lunch
13.00–15.00 The requirements of IEC 62304 – Peter Jordan
15.00–15.30 Coffee Break
15.30–17.00 Implementing IEC 62304 in your business – Peter Jordan
Key topics:
– FDA requirements for SW
– The requirements of IEC 62304
– Implementing IEC 62304 in your business
Who should attend
– Regulatory managers
– Regulatory associates
– SW programmers
– SW managers
Speaker biographies
Connie Bundy: Mrs Bundy has over 30 years experience with FDA medical product regulatory and compliance – including employment with FDA and 23 years as an independent consultant. Product experience includes Class I
– III devices, IVDs, biologics, and combination products. Extensive experience with assisting foreign companies with the FDA regulations. Over the last 13 years, Connie has traveled to Scandinavia about 4 times a year to meet with clients there and help them with FDA product approval submissions and compliance issues.
Peter A Jordan BA, C Eng, MBCS: Peter took his degree in Nuclear Physics prior to the existence of any courses in computing. For his last 18 years in full-time employment, he worked on cancer therapy treatment systems, most recently for Elekta Ltd. He has extensive experience of software process improvement and software human factors as a practitioner and manager, and as a quality auditor of Elekta’s suppliers. Peter is the United Kingdom Principle Expert on two IEC/ISO joint working groups: IEC SC 62A/JWG 3: Medical device software, and IEC SC 62A/JWG 4: Medical devices – General requirements for safety and essential performance – Usability. Peter is semi-retired and currently works as an independent consultant.
Registration information
Latest date for registration: November 16th (Please note that there are a limited number of seats available.)
Cost
The cost for the seminar is 750 euro/person (+VAT), which will be invoiced upon registration.
The following discounts are offered:
– 10% discount for additional persons from the same company (only valid if registered at the same occasion) or local partners (see list at www.synergus.se) and for those who register for one of the other seminars mentioned in this brochure.
– 20% discount for members of EUCOMED.
– 40% discount for government and academic researchers (limited number of seats available for this category).
Seminar venue
The Scandic Copenhagen hotel is located in the heart of Copenhagen, near good train and bus connections
and 10 km from the International airport.
About the hotel www.scandic-hotels.com/copenhagen
Information about accommodation is available on www.synergus.se.
To read more about the event and registre click here.