Thursday, May 18, 2017

Seminar Topics:

• Current guidance around Medical Electrical Equipment for FDA 510(k)s & Health Canada
• IEC 60601-1 series:
  • • Intro to IEC 60601 -1 series with Collateral & Particular Standards
    • Design & compliance to IEC 60601-1 3rd edition (including AM1)
    • Changes to the 60601-1 series and supporting standards: Updates on what’s new and draft documents that may impact your Compliance strategy
• ISO 14971:2007 Risk Management File (RMF) Overview

See the detailed Seminar Agenda.

Sign-up for Workshop Closed

Bio’s of Presenters

Leo Eisner, principal medical device product safety & regulatory consultant of Eisner Safety Consultants.
Leo’s firm specializes in helping medical device manufacturers through product safety, international regulatory and quality system processes. He has been called the “IEC 60601-1 Guy” by his clients and associates. Leo’s focus is on active medical electrical equipment including home use and wearable devices. Leo is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx standards), convener of IEC SC62D JWG9 (IEC/ISO80601-2-58) & a committee member of US TAG for TC62, SC62A, SC62D, & SyC AAL (Active Assisted Living System Committee – Home use medical and non-medical devices). Leo is a registered professional engineer in safety and has over 30 years experience in product safety. Leo is a member of RAPS, AAMI, ASQ, & IEEE. He’s manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment.

Peter Keith P.Eng, Senior Engineer and Technical Certifier at TÜV SÜD Canada Inc.
Peter is the lead medical services engineer at TÜV SÜD Canada with 10 + years of safety evaluation and regulatory experience, specializing in safety certification of medical and laboratory equipment such as hospital beds, ECGs, therapeutic lights, TENS, Lasers and more. Peter has participated on technical committees such as CACES (Canadian Advisory Committee on Electrical Safety) and assisted on the development of CSA SPE – 3000:2015. Peter is a licensed professional Engineer in Ontario and has evaluated over 400 medical and laboratory projects and given various seminars on regulatory and standards compliance.

Seminar Agenda:

Meet and Greet (9:00 AM)

Introduction to TÜV SÜD Canada & Presenter’s Backgrounds (9:15 AM)

Current US & Canadian Guidance for Medical Electrical Equipment
(9:30 to 10:45 AM)

Break time (15 Minutes)

Intro to IEC 60601-1 series (11:00 to 12:00 PM)

Q & A for Morning Session (12:00 – 12:15 PM)

Break for Lunch (lab tour and test demo) (12:15 to 1:30 PM)

Design and Compliance to 60601 – 1 3rd edition (1:30 to 2:30 PM)

Upcoming Standards Changes and Updates Related to 60601 Series
(2:30 to 3:30 PM)

Break time (15 Minutes)

ISO 14971:2007 Risk Management File (RMF) Overview (3:45 – 4:45 PM)

Q & A

Past posts to refer to includes:

• Electronic IFUs for EU MDD & AIMDD Devices
• EC publishes draft regulation on electronic IFUs of Medical Devices

The following text has been taken straight from the Health Canada website on the page for this final guidance document

“A draft version of this guidance document was first published and released for consultation in 2006. Comments from stakeholders and the Scientific Advisory Panel on Reprocessing of Medical Devices have been considered in producing this final version.

To reduce the risks associated with the use of reprocessed reusable medical devices, Health Canada has developed this guidance document to aid manufacturers of Class I, II, III and IV reusable medical devices in the preparation of reprocessing and sterilization information to be provided with these devices.

The guidance document is intended to assist manufacturers in understanding and complying with the regulatory requirements of section 21(1)(i) of the Medical Devices Regulations as they pertain to the directions for use for reusable medical devices. This guidance document should be used in conjunction with the Guidance Document on Recognition and Use of Standards under the Medical Devices Regulations.

In order to provide industry with sufficient time to meet the specifications of the guidance document, Health Canada will allow a six-month transition period commencing on the date of implementation, June 1, 2011. Following the transition period, Health Canada will expect manufacturers to meet the specifications listed in the guidance document.

Further information on this guidance document, and a summary of comments received and Health Canada’s responses to them, may be obtained by contacting:

Device Evaluation Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
Phone: 613-954-0297
Fax: 613-957-9969
E-mail: DED_manager@hc-sc.gc.ca

Published by authority of the Minister of Health

Date Adopted 2011/06/01

Effective Date 2011/06/01

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.”