ISO 13485 - Medical Devices: Quality Management Systems

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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