ComplianceOnline

The objective of the Seminar is to teach participants how to use the current ISO 10993-1 and FDA standards to establish a Biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for Biological risks but also understand when testing is not necessary. We will also cover how to properly document these findings and fill out a Biological evaluation report.

Why Should You Attend:

All medical devices that have direct or indirect contact with the human body require an assessment of the Biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies emphasize the use of risk-based approaches to assess Biocompatibility.

Who will Benefit:

  • Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment.
  • Medical device, pharmaceutical, and combination product start up and established companies.

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • Certification
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

July 30th, 2020 (8:00 AM to 2:00 PM PDT)

  • Risk-based approach to Biocompatibility evaluation strategy ·
  • Overview of current ISO 10993-1 and collateral standards Biocompatibility testing guidelines, costs, and turnaround times.
  • Chemical characterization, leachables and extractables (L&E) testing, and toxicology assessments.
  • Alternative testing to costly and time-consuming long-term animal testing.
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

Mike has over 30 years’ experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.

Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.

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

Register Now

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

(After registration, we will video stream the training on your convenient dates)

$7,999.00

Group-Max. 10 Attendees

(After registration, we will video stream the training on your convenient dates)



Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

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 E. Bayshore Road Suite 260
Palo Alto, CA 94303
USA

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 @ customercare@complianceonline.com

Payment:

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 for In-person Seminars:

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.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) 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. Some topics and speakers may be subject to change without notice.
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