US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach

Instructor: Juan M Campos
Product ID: 706301
Training Level: Advanced
  • 7
  • February 2020
    Friday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min
This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach.

Live Online Training
February 07, Friday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$229.00
One Dial-in One Attendee
$599.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$399.00

Live + Training CD/USB

$499.00

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Read Frequently Asked Questions

Why Should You Attend:

Companies conducting business in various geographical regions have to address numerous specific regulatory requirements from each of those geographies. This webinar will provide practical tools to address specific requirements from US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements from an unique Quality Management System (QMS) architecture ensuring compliance with those regulations.

The webinar will discuss in detail how to address the gaps between US, Canada, Brazil, Japan, Australia and EU ISO 13485:2016 requirements for:

  • Management responsibilities
  • Device marketing authorization
  • Facility registration
  • Measurement, analysis & improvement
  • Adverse events & vigilance reporting
  • Design and development
  • Manufacturing and service controls
  • Purchasing activities

Areas Covered in the Webinar:

  • Management responsibilities
  • Device marketing authorization
  • Facility registration
  • Measurement, analysis & improvement
  • Adverse events & vigilance reporting
  • Design and development
  • Manufacturing and service controls
  • Purchasing activities

Who Will Benefit:

  • Quality Assurance Managers / Directors / VPs
  • Regulatory Compliance Managers / Directors /VPs
  • Regulatory Affairs Managers / Directors / VPs
  • Clinical Managers / Directors / VPs

Medical Device industries conducting or planning to conduct business in the European Union

Free Materials:

  • Reference documents
Instructor Profile:
Juan M Campos

Juan M Campos
Owner, JMC Medical Device Consulting

Juan M. Campos is a Medical Device professional with + 32 years of continued industry experience. His main areas of expertise include Quality Assurance, Regulatory Compliance and Regulatory Affairs. He has led culturally and geographically diverse QA/RA teams in Spain, UK, France, Switzerland, Netherlands, Germany, Portugal, Italy, Greece and Turkey directly reporting to him. Additionally he has successfully coordinated global QA/RA projects with extended on site presence in USA and China. Most of the Regulations that govern today’s Medical Device world (EU Medical Device Directive, US FDA CFR 21-820, ISO 13485, Japan MHLW, Australia TGA, Brazil ANVISA, Health Canada, China SFDA, etc) have been created, implemented and even revised several times during Juan’s 30 year daily industry activity in leadership QA/RA roles. Specifically Juan has successfully led both product international Regulatory Registration processes, together with Regulatory Compliance global projects to ensure full Quality System compliance with those Regulations (Quality System design and implementation, Regulatory Agency pre-inspection readiness, Regulatory Agency post-inspection remediation, M&A due diligence and post-merger integration, product quality claims & liability, etc) in manufacturing, subcontractor and distribution facilities around the globe. Juan is also a certified SGS ISO 9001 Auditor, BSI ISO 13485 Lead Auditor and SGS MDR QMS Auditor & Product Assessor with extensive EMEA, China and USA on site audit experience, an active voting member of ISO TC150 CTN91 Implants and ISO TC210 CTN111 SC3 Quality Management Committees, as well as an active project evaluation expert at the BioExpert Network.

Follow us :
Fundamentals of EU MDR and IVDR
Advertising and Promotional Requirements for Drugs and Medical Devices

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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