This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices.
Why should you Attend:
For people in the medical devices industry which either develops or planning to market medical devices to USA and Europe and plan to implant a QMS that complies with both regulatory authorities and ask themselves how to do it correct and efficiently.
Areas Covered in the Session:
Brief review of regulations and standard: status and history
ISO 13485:2016 short review
Quality management system
Measurement, analysis and improvement
Who Will Benefit:
Medical Devices Quality Personal (QA and QC)
R&D Researchers of Medical Devices and Combined Products
Quality Control Staff
Regulatory Affairs (RA) Staff
Eyal Lerner is owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues: Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection, compliance gap analysis, 3rd party audits, Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 and Validation.
Event Fee: One Dial-in One Attendee Price: US$150.00