Medical Device Classification and Labelling
DURATION : One (1) full day
INTRODUCTION
The amount of scientific based evidence to be presented by manufacturers in support of the conformity assessment on its medical devices is reliant of the risk classification of its medical devices – which may defer in different jurisdictions. And in today’s ever increasingly regulated medical device market, exhausting the right amount of resource to obtain & collate the correct information as well as to label its medical devices appropriately could either mean success or failure of a manufacturer to get its product to market on time (or at all).
This course aims to guide participants in identifying the correct classification and labelling requirements to ensure unwanted waste of resources in meeting both specific and harmonized cross-jurisdiction requirements as well as to ensure timely market entry.
Participants will be led by an accomplished tutor with over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed. The course is designed to ensure participants understand the requirements towards successfully navigating regulatory requirements and placing compliant products to market.
COURSE OBJECTIVES
Gain a working understanding on the following to enable compliance to regulatory requirements:
INTRODUCTION
The amount of scientific based evidence to be presented by manufacturers in support of the conformity assessment on its medical devices is reliant of the risk classification of its medical devices – which may defer in different jurisdictions. And in today’s ever increasingly regulated medical device market, exhausting the right amount of resource to obtain & collate the correct information as well as to label its medical devices appropriately could either mean success or failure of a manufacturer to get its product to market on time (or at all).
This course aims to guide participants in identifying the correct classification and labelling requirements to ensure unwanted waste of resources in meeting both specific and harmonized cross-jurisdiction requirements as well as to ensure timely market entry.
Participants will be led by an accomplished tutor with over 2 decades of practical experience in the subject matter gained from auditing, training and quality assurance as well as management system development activities. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed. The course is designed to ensure participants understand the requirements towards successfully navigating regulatory requirements and placing compliant products to market.
COURSE OBJECTIVES
Gain a working understanding on the following to enable compliance to regulatory requirements:
- General Principles of Classification
- Overview of Classification in selected regulated markets: European Union; US; Canada; Japan; Australia; and Malaysia
- Understand the Language & Labeling Requirements
- Symbols to be used with medical device labels, labeling and information to be supplied
- Harmonized Approach - Global Harmonised Task Force (GHTF) / IMDRF
TARGET AUDIENCE
PRE-REQUISITE
Knowledge of medical device manufacturing and understanding of ISO 13485:2003/21 CFR 820.
DURATION
One (1) full day
iNTERESTED TO FIND OUT MORE?
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347
- Quality Managers
- Regulatory Affairs Managers
- Cross functional team members of implementation project
PRE-REQUISITE
Knowledge of medical device manufacturing and understanding of ISO 13485:2003/21 CFR 820.
DURATION
One (1) full day
iNTERESTED TO FIND OUT MORE?
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347