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BSI will now co-host the most comprehensive medical device training library in the world thanks to a collaborative partnership with the World Medical Device Organization (WMDO).
This new agreement with WMDO means that BSI will shortly have the capability to provide regulatory professionals with unlimited access to a suite of online medical device training courses to complement BSI’s existing instructor led training portfolio.
The medical sector has recently highlighted the need for a greater focus on professional training at a time when budget and time are at a premium. WMDO’s extensive catalogue of over 130 device-specific online training courses will therefore enable BSI to provide new eLearning techniques to bring medical device staff ‘up to speed’ with regulations and best practice processes through new distance learning options... Read more »
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The worldwide medical device community has been awaiting reports on an internal review conducted by FDA’s Center for Devices and Radiological Health since it’s initiation in 2009. This interest was not simply generated out of curiosity from those of us that spend too much time focused on how to achieve FDA approval of medical devices and assuring they are manufactured/marketed/sold in compliance with FDA’s regulations
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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.
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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.
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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.
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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.
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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.
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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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This course will provide clinical project managers with a fundamental understanding of legal operations to ensure optimization of negotiating clinical investigation agreements including terms and responsibilities.
Here you will learn the basic principles and mechanisms that make up a clinical investigation agreement as well as what is to be regulated or included in any clinical investigation agreement.
This course is vital for all those who intend to learn how to negotiate agreements with investigation sites and investigators, and as a requisite to the course: “Negotiating EU Clinical Investigation Agreements”.
See full course description here
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0 COMMENT(S)
As a former scientific reviewer within ODE, I was not at all surprised to see the internal survey results of how “intended use” and “indication for use” were inconsistently interpreted and applied. This issue has been around and debated internally since the mid to late 80’s and has never truly been addressed directly by the Agency. This inconsistency of interpretation can either cause a major surprise during a 510(k) review or can render a marketed device misbranded and adulterated for being promoted for an unapproved use. This inconsistency deserves the Agency’s highest attention since it can create a major problem for the manufacturer. At one end of the spectrum a finding of not substantially equivalent during a 510(k) review can end a product or a company. At the postmarketing phase of the product lifecycle, a misbranding/adulteration violation of the FD&C act can cause a suspension of sales of the medical device and litigation as a result of a serious injury/death due to use of the medical device for unapproved uses.
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