HSC Academy offers MDSAP Lead Auditor, Excellence & Strategic Leadership. It is a 42-hour live online course, based on MDSAP AU P0002.011, with Exemplar Global certification. For internal audit teams, see the MDSAP Internal Auditor course. Confirm that course's duration, format and dates with the team.

Minimum attendance of 75% and a minimum mark of 70%. HSC is a Recognized Training Provider (RTP) recognised by Exemplar Global.

Contact the HSC team to define the training scope for your company and confirm duration, format and dates.

Recorded Module 1 is a prerequisite for joining the Lead Auditor sessions. Contact the team for guidance on participation.

MDSAP (Medical Device Single Audit Program) is an international IMDRF programme allowing medical device manufacturers to undergo a single audit by a recognised auditing organisation, meeting the requirements of 5 countries simultaneously: Brazil (ANVISA), the United States (FDA), Canada (Health Canada), Japan (PMDA) and Australia (TGA).

An average of 6 to 12 months, from the initial assessment to the certification audit. The timeframe depends on the maturity of the existing QMS: companies that have already implemented ISO 13485 can usually achieve shorter timelines.

The Client Area is HSC Academy's learning platform. Sign in at https://learning.academy.hscglobal.com.br/auth/login. If you do not yet have an account, use the “Register for free” button at the top of the site.

You can contact us on WhatsApp at +55 11 2574-0785, call +55 11 2574-0785, email contato@hscglobalgroup.com or open Theo on this page. For specific technical questions, we recommend WhatsApp, with a response within 24 working hours.