ISO 13485 - Medical Devices: Quality Management Systems

Speaker

Instructor: Peter Spath
Product ID: 702743
Training Level: Intermediate to Advanced

Location
  • Duration: 90 Min
This ISO 13485 requirements training will provide guidance to medical device companies in developing an adequate Quality Management System (QMS) in accordance with ISO 13485 and FDA expectations. This webinar will also benefit medical device companies that are planning to market their products in Europe.
RECORDED TRAINING
Last Recorded Date: Feb-2013

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Why Should You Attend:

Medical device manufacturers that are planning to market their products in Europe must develop a quality system in accordance with ISO 13485 to obtain a CE marking. It will also help to increase efficiency, cut costs and to meet customer satisfaction. Complying with ISO 13485 will aid in gaining marketing permissions and certification from FDA and achieving access to more markets across the globe.

This 90-minute webinar on quality management system for medical device manufacturers will focus on the key requirements of the ISO 13485 standard. It will also discuss the requirements for internal audit and how to meet the FDA medical device audit expectations.

Areas Covered in the Webinar:

  • Overview of ISO 13485 Quality Management System.
  • Discussion of key requirements.
  • What written procedures and training are required.
  • How should internal audits be conducted.
  • Understanding of what auditors expect.

Who Will Benefit:

  • Medical Device Quality Assurance Managers/Personnel
  • Medical Device Regulatory Managers/Personnel
  • Medical Device Manufacturing managers, supervisors & personnel
  • Internal Auditors
  • Senior management executives (CEO, COO, CFO, etc.) of medical device companies
  • Medical Device Project Managers

Instructor Profile:

Peter Spath, is currently a freelance consultant serving the Medical Device community by providing a variety of quality and regulatory consultation on contractual basis remotely and on-site. Services include: leading Quality System audits in accordance with ISO 9001, 17025, and 13485, Canada‘s CMDCAS regulations and FDA GMPs for both Medical Devices and Combination Devices. He has over 20 years of experience working with international regulations and standards as a Certified Lead Auditor. Recognized as an expert in ISO Standards and Federal Regulations, especially those governing Electronic Records and Electronic Signatures, he led regulatory compliance assessments throughout Fortune 500 Companies as well as their suppliers across the United States, Mexico, and Europe. Mr. Spath developed and facilitated the implementation of quality management systems in numerous internal organizations and key contract manufacturers in Germany. He has also successfully managed FDA GMP and EPA GLP investigations in a variety of organizations.

In addition to his expertise in Quality Systems and Regulatory requirements for Medical Devices, Mr. Spath has served on EPA committees to develop new regulations for environmental laboratory accreditation. He was also appointed to the Environmental Laboratory Accreditation Board, an EPA Federal Advisory Committee (FACA), providing advice to the EPA Agency Administrator.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

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