Cover Story

Invited Speakers : Abstracts & Introduction

Abstract:

• CE marking for Medical Devices

• Classification of Medical devices

• Five Steps for CE Marking

• Global Certification process of medical devices..

• CB scheme...

• FDA 510K, Health Canada and Japan Approvals.

• Introduction to TUV

“Exploring regulations of various countries on Medical Devices"

Manufacturers who wish to access these global markets for medical business need to follow and comply against the set rules and regulations set by individual countries.

The Medical Devices market is increasingly global and regulations are constantly evolving. Working with an experienced and recognized Notified Body can guide your organization through the regulatory requirements can bring confidence and many benefits to manufacturers.

In this seminar we learn and understand the

“Regulations of various countries on Medical Devices”

CE Mark

CE marking is a legal requirement for Medical Devices intended for sale in Europe.

Medical Devices sold within the European market must have CE Marking affixing to identify claims of safety and compliance with regulatory mandates. The European Union strictly controls the use of CE Marking on Medical Devices. To affix CE Marking, manufacturers may need to work with a recognized Notified Body, to confirm compliance with European regulation

Learn on Classification rules of Medical devices and process for CE Marking accordance to Directive MDD 93/42/ EEC - Medical device and 98/79/EC -in vitro diagnostic medical devices.

Implementation of For Quality Management System, the international standard ISO 13485 is an independent standard and was designed for companies in the medical devices sector. And building the Technical file on Medical product.

PAL- QMS / GMP Certifications process for access Japan Market

Manufacturer needs to show compliance against QMS/GMP Audit and certification in accordance with MHLW ordinance No. 169, as set by , Ministry of Health, Labor and Welfare (MHLW)

Premarket Notification 510(k) and third party review process

Premarket notification (PMN) submissions [510(k)]s for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the FDA.

The Office of Device Evaluation (ODE) within CDRH is responsible for the processing and review of 510(k)s and providing a decision related to clearance to market medical devices in the U.S.

Requirements of other major countries, like China, health Canada and Other.

Speaker’s Introduction

Qualified Medical Auditor from TVU Rheinland, with past experience over 15 years in Medical equipment Manufacturing industry. In the areas Production, Product safety testing, Engineering, Product Design and Safety and Regulatory engineering (SRE) and Management representative.

Summary of Qualifications:

• Expertise in Product testing and certification process, which includes safety, EMC (Electro Magnetic Compatibility) and environmental tasting. Global certification and CE marking process

• Over 2 years professional experience in conducting audit and certification Process with ref. ISO 13485: 2003 and CE certificates

• 15 years professional experience in manufacturing, Engineering, quality and Design activates of medical equipments

• ISO 9000:2000 certified auditor.

• Qualified EN ISO 13485:2003 and Medical Devices Directive (MDD) auditor for active medical devices from TRPS Germany

• Qualified ISO 13485:2003 auditor under CMDCAS for Health Canada

Education back ground : Electronics Engineer

Organization: TÜV Rheinland (India) Private Limited

A subsidiary of TÜV Rheinland Group, which is a global certification organization with its head quarter located in Cologne, Germany. TÜV Rheinland Group is one of the world largest certification companies. TÜV Rheinland Group is an internationally recognized authority for testing and certification of technical installations and products with over 150 years of experience, existing in more than 50 countries worldwide.

It is a European Union Notified Body appointed by the Federal Government of Germany and also National certification body in many countries and member of CB scheme. At present I am an Auditor - Medical devices for conducting the audits in medical industry on implementation of QMS in line with ISO 13485 and CE marking process.