ComplianceOnline

This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview about the program definition, the requirements for the quality management system, how a smart implementation of these requirements in the quality management system is possible and finally how the audit for five countries (Australia, Brazil, Canada, Japan, US) is working.

Why You should Attend:

You should attend this seminar to understand, what is MDSAP and how is MDSAP working. Your implementation time should be short and need smart ideas to reach the right level to pass the MDSAP - Audit by your audit organization.

This webinar will give you a clear structured overview and introduction, how to apply MDSAP-Requirements and how to implement the requirements into your quality management system. First you learn to identify the relevant requirements, second you learn how to implement the identified requirements into your quality management system based on ISO 13485:2016 or 21 CFR 820. The course based on the MDSAP Companion-Document, issued by the FDA

Areas Covered in the Session:

  • What is the Medical Device Single Audit Program (MDSAP)?
  • Which Companies must have MDSAP?
  • Which Companies should have MDSAP?
  • Which Companies should postpone MDSAP?
  • What are the requirements of MDSAP?
  • How to implement MDSAP in a smart way into an quality management system according ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
  • How the MDSAP-Audit is working?
  • What is the difference between MDSAP and European Notified Body Audits?

Who will benefit:

  • Medical Device Manufacturers who develop, manufact and / or sell to US, CAN, BR, AUS, JP. Those in the following roles will benefit
  • CEOs
  • Regulatory Affairs Managers
  • Quality Managers
  • Quality Representatives
  • Other managers who need to deal with regulatory or quality guidelines

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

November 13, 2020 (10:00 AM - 6:00 PM EST)


Areas Covered in the Seminar:

  • What is the Medical Device Single Audit Program (MDSAP)?
  • Which Companies must have MDSAP?
  • Which Companies should have MDSAP?
  • Which Companies should postpone MDSAP?
  • What are the requirements of MDSAP?
  • How to implement MDSAP in a smart way into an quality management system according ISO 13485, 21 CFR 820 (QSR) or any other regulatory framework?
  • How the MDSAP-Audit is working?
  • What is the difference between MDSAP and European Notified Body Audits?
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Frank Stein

Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

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

Register Now

Online using Credit card

$999.00

(One Dial-in One Attendee)

November 13, 2020, Virtual Seminar
(Registrations till October 20, 2020 - $999)
(Registrations after October 20, 2020 - $1499)

$5,095.00

Group-Max. 10 Attendees

November 13, 2020, Virtual Seminar
(Registrations till October 20, 2020 - $5095)
(Registrations after October 20, 2020 - $5995)



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),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

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

Note: In view of Coronavirus situation and travel advisory issued, ComplianceOnline will waive off all cancellation charges for the registrations till September 30, 2020.

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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