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This informative presentation outlines an initial assessment of the clinical evaluation aspects of the draft Regulation as a future substitute for the current Medical Device and Active Medical Device directives, made publically available on September 26th 2012.The main points covered are the changes in the clinical evaluation regulatory principles, followed by a gap analysis with ISO 14155 and a review of the clinical investigation process changes as proposed by the new regulation.



WMDO is proud to announce it's strategic partnership with EUCOMED and EDMA that offers their members access to WMDO's exclusive catalogue of professional online training. Under the agreement, EUCOMED and EDMA members will receive special benefits using the special login code provided on the EUCOMED website. 



Last September 27, 2012, WMDO held it's first CMDA exam for medical device clinical professionals in Switzerland and in the US. We want to congratulate our first graduates for their efforts and success in passing the exam. The next CMDA Clinical Evaluation exams will be held on April 5 and September 27, 2013 in Lausanne, Copenhagen, Singapore and Minneapolis (other locations upon request). Click here to know more about our Certification program.





0 COMMENT(S)

It’s no secret that clinical evaluation of existing data is mandatory for all medical devices and good practice (not to mention common sense) indicates it should be done before even starting a clinical investigation in humans. Many of us, even if we know the clinical arena inside-out, have found this process to be lengthy and sometimes not that straightforward at all! The European regulations are not the only ones requesting this process to be in place, it has become a worldwide approach for complying with essential principles for medical devices. The upcoming revision of the ISO 14155 now also includes the requirements in addition to many other regulatory documents throughout the world.



BY PAUL COHEN // 0 COMMENT(S)

TGA (Therapeutic Goods Administration) restructures its internal organization combined with an increased use of information technology to ensure a more efficient regulatory review and continuous post market supervision process. Two separate regulatory groups have been created, one that will focus on authorizations for product market access and another group monitoring products already on the market.



0 COMMENT(S)

Many of us have been in the frustrating and sometimes embarrassing, (if not costly) situation whereby seasoned clinical professionals will unwittingly interpret regulatory requirements in a different manner than their regulatory colleagues; not to mention the interpretive differences that arise when sales and marketing gets into the picture. While it’s nice to have a look from various perspectives, we have to admit that at some stage of the game the implications involved with this type of communication pattern can quickly lead to confusion and error, making the whole process unacceptable in today’s regulatory landscape.



BY DANIELLE GIROUD // 0 COMMENT(S)

It has been a while since the TC 194WG 4 produced the final version for the FDIS which was sent to the ISO committee end of March 2010. The FDIS is now finally out for formal voting since September 9th, 2010 with a deadline for voting on November 9th 2010.


Many clinical professionals wonder when the requirements of this new FDIS can be used. For clarification, after an FDIS, only editorial corrections can be made. As a consequence, the requirements of the ISO 14155 FDIS (2010) will not change with exception for some editorial corrections and clinical professionals can thus start using the new version.



BY DANIELLE GIROUD // 0 COMMENT(S)

How often have you heard someone say: “That will never happen!”, in response to a question about a potential risk of a medical device?  This is an assumption you should not be willing to make. The reality is, with most medical devices, if something does go wrong it may cause serious damage. The intention of this article is not to paint an overly dramatic picture nor to  create rampant paranoia, but to provide a realistic view of risk management.



BY GEORGIANN KEYPORT // 0 COMMENT(S)

This excellently documented 60 minute course will provide you with the necessary steps in preparing a regulatory submission for a medical device in the United States. The overview of the process steps include:

• Regulatory Submission Basics
• Submission Planning
• Submission Writing
• Supporting Documents and Data
• Lifecycle Management version

 



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