Ensuring first-time market access and thorough post market surveillance through effective design and execution of clinical evaluations and investigations

With the recent amendments to the Medical Device Directive (2007/47/EC), it is essential that you adapt your evaluations and investigations strategy to maintain complete compliance. However, it is also key that this change in directive does not impact on the bottom line of your company.

Pharma IQ’s Clinical Evaluations and Investigations for Medical Devices Conference will bring together regulators, notified bodies, medical device professionals and CRO’s all tasked with the same remit; medical device evaluations and trials.

This conference will offer attendees the opportunity to discuss the key challenges currently being faced as well as possible solutions and also gain immediate clarification over the new guidelines from the regulatory bodies represented.

Expert Speakers Include:

Dr Dirk Wetzel
Head of Division, Medical Devices
BfArM, Germany

Robert Higgins
Medical Device Regulations
MHRA, UK

Dr Gert Bos
Head of Clinical, and Regulatory Affairs
BSI Healthcare

Martin de Bruin
Director Medical Businessline
KEMA Quality/DEKRA Notified Body

Stefan Menzl
Director Regulatory Affairs, Compliance Europe, Africa,Middle East
Abbott Medical Optics, Germany

Ian Quirk
Worldwide Director, Clinical and Regulatory Affairs
Ranier Technology Limited

» Click here for full speaker list

The Expert Speaker Panel Will Help You To:

Gain critical regulatory updates on the change to the MDD (2007/47/EC), how other companies have risen to this new challenge and how you can do the same: Abbott Medical Optics share their experiences from recent CE qualifications

Ensure complete regulatory compliance and operational effectiveness through assessing best practice approaches in designing your clinical investigation: ev3 and Boston Scientific share their recent experience

Make sure your project is progressing on time and on budget when outsourcing by establishing key performance metrics and parameters to maintain control: Orbusneich Medical discuss the most effective methods and how you can implement them

Keep your product on the market by ensuring effective, compliant post market surveillance with guidance from Ranier Technology Ltd. and Cryolife Europa Ltd.

Achieve market access by executing thorough clinical literature reviews and establish best practice: Siemens AG share their experience

Conference Partners
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