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Webinar On CE Mark: Content and Format for a Technical File and Design Dossier

  May 11, 2015  

Compliance Trainings, Online

Description :

This presentation is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices. 

This presentation is further intended to provide practical, actionable, and sustainable guidance on the regulatory requirements set out in the three directives (MDD, IV(M)DD, and AIMDD).

Understanding and accurate interpretation of the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, leading to saving an enormous amount of your time, efforts and resources and resulting in bringing innovative medical products to the EU market faster. 

This presentation will offer you great opportunities to learn about three directives (MDD, IVDD and AIMDD) and regulatory requirements including postmarket requirements and compliance.  At the end of the presentation, you will get familiarized with the applicable EU directives governing medical devices including in-vitro diagnostic and active implantable medical devices, helping you implement regulatory requirements smooth and fast.

Areas Covered in the Session :

How EU laws are made

Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices

CE Marking Principles

Device Classification

Medical Device Directive (MDD)

In Vitro Diagnostic Device Directive (IV(M)DD)

Active Implantable Medical Device Directive (AIMDD)

2007/47/EC Amending MDD and AIMDD

Globally Harmonized Technical File And Design Dossier

Declaration of Conformity

Clinical Evaluation

Postmarket Requirements: Surveillance and Vigilance

Harmonized Standards

EN ISO 14971:2012, EN ISO 13485:2012, and ISO 14155


MEDDEV Guidance Documents

Update on the EU Regulatory Scheme

Good Practices

Speaker’s PASS-IT Suggestion/Recommendations


Who Will Benefit:



Compliance Officers


Complainant Managers

Managers (RA, QA/QC, CA)


Contractors and Subcontractors

Price tags:


Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899


Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

Organized by: Compliance Trainings
Invited Speakers: Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor 
Deadline for Abstracts: 2015-06-10

For more information about this event please visit


E-mail: suzzane.d@compliancetrainings.com
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