How to Comply with both in the Same Organization

Overview:

Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

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:

• Introduction
• Brief review of regulations and standard: status and history
• ISO 13485:2016 short review
• Principals
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement

Who Will Benefit:

• Medical Devices Quality Personal (QA and QC)
• Laboratory Managers
• R&D Researchers of Medical Devices and Combined Products
• Quality Control Staff
• Regulatory Affairs (RA) Staff

Speaker Profile
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 (internal audits), compliance gap analysis, 3rd party audits (FDF and API's), Management Review, GMP, GLP,MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation.