Dear All, I am looking into step by step procedure for approving a medical device - worn by patients with heart problems on the wrist on a daily basis. Device includes non-invasive sensors for diagnosis of body temperature, blood pressure, ECG and oximeter. The device includes a GSM modem by Siemens TC35, an antenna like on a cellphone, a lithium battery pack, a microcontroller unit, flash memory and a data link controller, all on printed boards within this high density packaged medical device. My questions are as follows:
1. What is the procedure to obtain GSM radio approvals in 1) Europe 2) Canada 3) US? 2. What are the applicable GSM radio standards in Europe, Canada and US? 3. What are some well known labs in Europe which can give radio approvals quickly and efficiently. 4. Assuming the TC35 GSM modem module within the device has CE for Europe under the RTTE, is there a requirement to obtain radio approvals on the complete device in Europe? 5.. Assuming the TC35 GSM modem module within the device has US and Canada radio approvals, is there a requirement to obtain radio approvals on the complete device in North America? 6. Does Canada have a similar approval procedure like the FDA in the States regarding medical devices? 7. Can this product be FDA approved under the 510K program (ie is there a similar product out there)? 8. What would be the environmental requirements for this type of device? PETER S. MERGUERIAN Technical Director I.T.L. (Product Testing) Ltd. 26 Hacharoshet St., POB 211 Or Yehuda 60251, Israel Tel: + 972-(0)3-5339022 Fax: + 972-(0)3-5339019 Mobile: + 972-(0)54-838175 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: pstc_ad...@garretson.org Dave Heald davehe...@mediaone.net For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.rcic.com/ click on "Virtual Conference Hall,"
