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ISO 13485 - Medical Devices: Quality Management Systems

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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.

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

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:

Who Will Benefit:

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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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 only 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."
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Training Options Training Duration = 90 Min
$299.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$499.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days