CE Marking under Medical Device DirectiveDate : 28-29 September 2016
Time : 9am - 5pm Venue : G Hotel Gurney, Penang Enjoy Early Bird Course Fees when you register by 1 September 2016.
Early Bird (AMMI Members) - RM1,200 per pax Early Bird (Non Members/ Public ) - RM1,400 per pax NORMAL COURSE FEES AMMI Members - RM1,400 per pax Non Members/ Public - RM1,600 per pax Note : Price stated is not inclusive of 6% GST |
Click here to download course brochure.
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INTRODUCTION
This course is designed to provide participants with the knowledge on medical device market access into the European Economic Area. Internal and external auditors and management personnel responsible for quality systems for medical device manufacturers will benefit from this course. Participants will gain an overview of the requirements of the Medical Device Directive and the CE Marking approach.
COURSE OUTLINE / OBJECTIVES
• Obtain an overview of the Structure of the Medical Devices Directive
• Gain an understanding of EU Classification of Medical Devices
• Obtain an overview of the European CE Marking Approach
• Recognize the Role of Standards, Essential Requirements, and Labeling
• Obtain an overview of Post Market Surveillance and Vigilance
TARGET AUDIENCE
PRE-REQUISITES
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Basic awareness on medical devices, quality assurance, and recognized standards (ISO 13485:2003 & ISO 14971:2007) is also recommended.
DURATION
Two (2) full days
PAYMENT
Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice
Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL
Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector
A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment
You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : admin@medsociate.com
SUBSTITUTION
Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION
Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT
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
This course is designed to provide participants with the knowledge on medical device market access into the European Economic Area. Internal and external auditors and management personnel responsible for quality systems for medical device manufacturers will benefit from this course. Participants will gain an overview of the requirements of the Medical Device Directive and the CE Marking approach.
COURSE OUTLINE / OBJECTIVES
• Obtain an overview of the Structure of the Medical Devices Directive
• Gain an understanding of EU Classification of Medical Devices
• Obtain an overview of the European CE Marking Approach
• Recognize the Role of Standards, Essential Requirements, and Labeling
• Obtain an overview of Post Market Surveillance and Vigilance
TARGET AUDIENCE
- Regulatory and quality staff responsible for preparing or hosting CE Marking audits
- Organizations wishing to enter the EU & EFTA market with medical devices
- Those who need an understanding of the New European CE Marking approach for medical devices
- Companies preparing 'own brand' or 'private labeling' devices
PRE-REQUISITES
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Basic awareness on medical devices, quality assurance, and recognized standards (ISO 13485:2003 & ISO 14971:2007) is also recommended.
DURATION
Two (2) full days
PAYMENT
Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice
Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL
Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector
A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment
You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : admin@medsociate.com
SUBSTITUTION
Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION
Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT
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