The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. However, today’s advanced medical devices usually consist of unique combinations of mechanical, electrical and electronic components and technologies that are frequently controlled by software or programmable controllers. As a result, international regulations and standards applicable to medical devices are being continuously revised and updated to reflect potential safety issues that can result from increasingly complex device designs.

First published in 1977 by the International Electrotechnical Commission (IEC), IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, is the internationally recognized standard addressing general requirements for medical electrical equipment and devices. IEC 60601-1 has undergone a number of significant revisions over the years in an effort to remain current with new and advanced medical technologies. The latest set of changes was introduced with the 2012 publication of Amendment 1 to IEC 60601-1.

This seminar provides an overview of the IEC 60601. It also covers the modified requirements presented in IEC 60601-1 Edition 3.1. Beginning with a brief summary of the history of the standard, the seminar then offers a detailed review of the significant additions and changes presented in Amendment 1, as well as information on other changes that may affect medical device manufacturers, and concludes with some guidelines and recommendations for manufacturers.

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

After completing this seminar, participants should be familiar with the full scope of IEC 60601-1, including the current version. The topics covered will include:

  • Determine the applicable medical equipment requirements to design products for compliance
  • Risk Assessment, Designing a Risk Management system
  • Establishing essential performance limits on medical electrical equipment, and evaluating these performance characteristics under abnormal or fault conditions
  • Requirements for PEMS (programmable electrical medical systems)
  • Humidity testing requirements
  • Mechanical hazards
  • Temperature testing
  • Marking and labeling
  • Documentation, user manuals, instructions for use (IFU)
  • Define insulation parameters and requirements
  • Generate diagrams that determine creepage, clearance, insulation thickness, and dielectric strength requirements
  • Determine appropriate grounding, fire protection, and mechanical requirements
  • Identify performance testing

Areas Covered :

The areas that will be discussed in the seminar will include the following topics throughout the agenda:

  • History of IEC 60601-1
  • Overview of collateral standards, i.e., IEC 60601-1-XX
  • Overview of particular standards, i.e., IEC 60601-2-XX and IEC/ISO 80601-2-XX
  • Review of ISO 14708, Active Implantable Medical Devices
  • Review of 14971 Risk Management File
  • Review full scope of IEC 60601

Who will Benefit:

  • Medical Device Industry Managers, Supervisors, Employees
  • Electronic Industry Managers, Supervisors, Employees
  • Quality Assurance Personnel
  • Technical Consultants
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 08.59 AM: Registration and Meet & Greet.
  • 09.00 AM - 10.00 AM:
    • Seminar outline
    • History of IEC 60601-1
  • 10.00 AM - 11.00 AM:
    • Overview of collateral standards, i.e., IEC 60601-1-XX
    • Overview of particular standards, i.e., IEC 60601-2-XX and IEC/ISO 80601-2-XX
  • 11.00 AM - 12.00 PM:
    • Review of ISO 14708, Active Implantable Medical Devices
    • Review of 14971 Medical devices –Application of risk management to medical devices
  • 12.00 PM - 01.00 PM: Lunch
  • 01.00 PM - 02.00 PM: Review full scope of IEC 60601
    • Terminology and definitions
    • General requirements
  • 02.00 PM - 03.00 PM:
    • General requirements for testing ME equipment
    • Classification of ME Equipment and ME Systems
  • 03.00 PM - 04.00 PM:
    • ME Equipment identification, marking and documents
    • Protection against electrical Hazards from ME Equipment
  • 04.00 PM - 04.30 PM:
    • Review & Summary
    • Adjourn
Day 02(8:30 AM - 12:30 PM)
  • 08.30 AM - 10.00 AM: Review full scope of IEC 60601 (continued)
    • Protection against Mechanical Hazards of ME Equipment and ME Systems
    • Protection against unwanted and excessive radiation Hazards
    • Protection against excessive temperatures and other Hazards
  • 10.00 AM - 11.00 AM:
    • Accuracy of controls and instruments and protection against hazardous outputs
    • Hazardous situations and fault conditions for ME Equipment
    • Programmable Electrical Medical Systems (PEMS)
  • 11.00 PM - 12.00 PM:
    • Construction of ME Equipment
    • ME Systems
    • Electromagnetic compatibility of ME Equipment and ME Systems
  • 12.00 PM - 12.30 PM: Seminar wrap up
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Mike Colvin

Mike Colvin Ph.D
Medical Device Technical Adviser/Consultant

Dr. Mike Colvin has over 30 years direct experience in managing Biocompatibility assessment and testing, working in the medical device and combination products field. He has worked on/contributed to many domestic and international Biocompatibility committees, and has been a consultant to the medical device industry on the proper Biocompatibility strategies for success.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card


Seminar One Registration

May 10-11, 2018, Minneapolis, MN
(Registrations till April 2, 2018 - $1299)
(Registrations till April 15, 2018 - $1499)
(Registrations after April 15, 2018 - $1599)

$7,794.00 (23%)*

Save $1,795.00

Special Group Discount Register for Six attendees

May 10-11, 2018, Minneapolis, MN
*Hurry! This option is limited and based on availability.
Great Saving with Group Ticket!!! Only 3 left

Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.

For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.


  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Minneapolis, MN
    (Venue to be announced shortly)

    May 10-11, 2018

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this event, please contact Event Manager: or call: +1-650-238-9656

    Media Partner:

    Media Partner

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    Local Attractions of Minneapolis, MN

    Cathedral of St. Paul

    Cathedral of St. Paul

    Built in 1915 on the highest point in the city, this cathedral is one of the largest in the country. A replica of St. Peter's in Rome, the building boasts a newly restored 175-foot-high copper dome, a massive rose window, and granite-and-travertine construction.

    Frederick R. Weisman Art Museum

    Frederick R. Weisman Art Museum

    Set on a bluff overlooking the Mississippi River, the Weisman Art Museum is part of the University of Minnesota campus. You won't miss the trademark Frank Gehry-designed building; its fluid form defies conventional architectural lines, and its metallic finish gleams in the sunlight. The permanent collection is especially strong in American modernist paintings, ceramics, Mimbres pottery, and Korean furniture.

    Historic Fort Snelling

    Historic Fort Snelling

    This living history museum commemorates the establishment of a fort here in the wilderness in 1819 by Col. Josiah Snelling and his troops, who opened the area for homesteaders. Costumed guides are the focus of a living history reenactment during the summer months, re-creating the activities of everyday army life during the 1820s.

    Mill City Museum

    Mill City Museum

    Minneapolis's Mill City Museum recounts the history of the flour industry that earned the city the nickname "Mill City" in the late 19th century. Set in the ruins of what was once the world's largest flour mill the museum re-creates old milling techniques with period equipment railroad cars and interactive exhibits. Visitors also learn the impact of the nation's first high-quality finely milled flour on the gastronomy of the Twin Cities and the country.

    Minneapolis Institute of Arts

    Minneapolis Institute of Arts

    More than 5,000 years and 80,000 pieces of fine and decorative arts comprise the permanent collection at the MIA, including a 2,000-year-old mummy, European masters (Rembrandt, Titian, and Monet, among others), architectural and decorative arts, and a comprehensive photography exhibit. If you're short on time, ask for the "Highlights" brochure to make sure you don't miss the museum's best.

    Minnesota History Center

    Minnesota History Center

    An impressive array of artifacts is housed in this three-story museum, including photographs, music, and videos, all of it celebrating Minnesota history. Kids enjoy sitting in the re-created basement of a Minnesota farmhouse while a simulated tornado passes overhead. Adults enjoy listening to recordings of Minnesota musicians, including Bob Dylan, Steven Greenberg, and Prince.

    Minnesota Museum of American Art

    Minnesota Museum of American Art

    Temporary exhibits are the rule at the Minnesota Museum of American Art, which overlooks the Mississippi River. Expect edgy, contemporary installation pieces, as well as paintings, fiber art, ceramics, works on paper, and works created from found objects.

    Minnesota Zoo

    Minnesota Zoo

    "Russia's Grizzly Coast" became the Minnesota Zoo's newest exhibit in 2008 bison pumas and wolverines -- as well as exotic mainstays like tigers camels dolphins and monkeys. The Minnesota Zoo also includes an IMAX theater and a monorail for easy navigation of the grounds.

    Mississippi River Visitor Center

    Mississippi River Visitor Center

    Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.

    Science Museum of Minnesota

    Science Museum of Minnesota

    Hands-on exhibits introduce visitors to natural history, science, and technology in this massive museum. Highlights include the Human Body Gallery, navigating a virtual towboat down the Mississippi River, and a collection of fossils and prehistoric specimens. In warm months check out EarthScapes Mini Golf, a new activity designed to teach earth surface dynamics. There's also an Omnitheater.

    University of Minnesota

    University of Minnesota

    One of the Midwest's oldest (1851) and most important universities, with 50,000 students on the Twin Cities campus, the UMN offers three significant museums -- the James Ford Bell Museum of Natural History, the University Art Gallery, and the Frederick R. Weisman Art Museum .The 4,800-seat Northrop Auditorium has been a home for distinguished performances since 1929, and the University Theatre has four separate stages.

    Walker Art Center/Minneapolis Sculpture Garden

    Walker Art Center/Minneapolis Sculpture Garden

    The Walker Art Center is as well known for its striking architectural features as for the edgy, contemporary art inside: paintings, sculptures, drawings, photographs, and multimedia installations. A fine-dining restaurant and cafe, both by Wolfgang Puck, and gift shop are also new. Across the street is the Minneapolis Sculpture Garden, the largest urban sculpture garden in the country. A variety of 20th-century sculpture shares space with horticultural plantings, including the famous "Spoonbridge and Cherry" sculpture.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

    We need below information to serve you better

    Best Sellers
    You Recently Viewed