Peter Spath
Quality System and Regulatory Affairs Consultant
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.
Upcoming Webinar
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Recorded Webinar
Post Approval Risk Management Strategy
We will discuss how Risk Management Files are developed and maintained in accordance with ISO 14971 throughout the product lifecycle.
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ISO 13485 Quality Management System
Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485. Such Quality Systems will also be beneficial for organizations seeking to gain marketing permission from the FDA.
Recorded Session Get life time access for one participant with download option!

Computer System and Software Validation
We will discuss ways Medical Device manufacturers can organize, document and prepare to present their software validation efforts during FDA Investigations or ISO Registrar audits.
Recorded Session Get life time access for one participant with download option!

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