How to Comply with both in the Same Organization

Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS).

At a Glance

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Registration Fee: $$150

Date and Location

Friday, February 16, 2018 -
10:00am to 11:30am

161 Mission Falls Lane, Suite 216,
Fremont, CA 94539
United States

Point of Contact

A point of contact has not been selected for this event.

Event Details

Event Size: 
25 - 50 Attendees
Event Type: 
Website URL: 
Related Sectors: 
Regions : 
United States

Full Event Description: 

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
    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, 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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407