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Many European regulatory authorities advise to work already now under the requirements of the ISO 14155:2011 despite the fact that the long awaited harmonization is still not implemented. The new version of the standard provides much clearer and in depth GCP guidance to the industry and health professionals for planning and conduct of medical device clinical investigations. Nevertheless, harmonization is imminent as in September 2011, the Annexes ZA and ZB of the standard have been approved by CEN…
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Should we or should we not start using ISO 14155:2011? Harmonization is definitely going to happen sometime in the fall of 2011. The format of the Annex Z has been adapted to the new requirements of the European Commission and CEN will proceed with the application for harmonization soon.
However harmonization should not be the sole and unique reason to start using ISO 14155:2011 versus the 2003 version. Many European Competent Authorities encourage manufacturers to apply the new version as it is clearly a more complete guidance document and definitely more in line with the 2007/47 updated requirements of the Medical Device Directives.
So clinical professionals should not wait to get up to speed with the content of ISO 14155:2011 and implement these into their Clinical Quality Systems as soon as possible.
To help you with this, WMDO has developed a complete 7 course online suite entitled: “ISO 14155: In Depth Review” which will get anybody quickly up to speed in under 4 hours.
For more information, click here: ISO 14155: In Depth Review
For non-clinical professionals, please see the condensed version here: ISO 14155:2011 A Summary Review
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WMDO In the medical device industry, control of digital activities - including social media - is paramount to avoid fines and ensure that proper strategies and structures are in place to maximize commercial opportunities. A four-step approach that is easily implemented, yet robust enough to help companies address the dual goals of reducing risk and increasing the return on their investments, must drive online marketing and communication activities.
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WMDO invites you to participate in this free, 30 minute live informational webinar followed by Q&A session, hosted by medtech communications expert Robert Hanvik. This exceptional opportunity is open to all medical device professionals and will provide you with an intriguing and informative look into the ambiguous world of social media.
From defining social media to facts and figures surrounding its usage, you will gain insight into the current state of thinking among regulators as well as expert interpretation of these thoughts and some practical considerations as you move ahead in your social media efforts. More important, this webinar will allow you to distinguish the types of questions you should be asking about what you can and cannot do with social media.
Who should participate?
All Medical Device Professionals engaged in social media activities – everyone in medical devices Legal, Compliance, Clinical, Regulatory, Quality Assurance, Reimbursement, Marketing, Communications, Digital Business, Human Resources, Training, Education
Wednesday, May 18, 2011
North America / 11:00am EST
Europe / 17:00 CET
Register here to reserve your free access - places are limited. |
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“Valuation Principles for Early Stage Companies” is the third article in the “Napkin to Market” series authored by Patrick Kullmann of CG3 Consulting.
Valuation Principles and the Angel Investor-Things That You Need to Know
In the last two months of LifeScience Alley News articles, I outlined the risks and the rewards of the early start medical device company in the fundraising process with “Rules of the Raise” - how to successfully raise financial resources in a difficult economic environment for your startup medical device company, and “First Things First”, how to successfully start a medical device company. This month we are focusing on the basic understanding of risk capital, the providers of risk capital and what angel investors are looking for in the valuation process. Understanding the angel investment process and managing expectations throughout the process for a successful outcome is….
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The ISO 14155:2011 has recently been published with many new requirements compared to the previous version throughout the document. For companies conducting clinical investigations with medical devices currently following the 2003 version, updates will be needed as soon as the document is harmonized by the European Commission (expected Q3 2011).
The new document contains major changes that will have a significant impact on the clinical quality systems and related documents such as case report forms and clinical investigation plans, informed consents and investigator brochures and more. In addition, understanding the relationship between clinical evaluation, clinical investigation and risk analysis becomes essential and will definitely need to be included in the quality system if not already done.
Given the many changes the document contains, clinical and quality assurance managers should not underestimate the work needed to incorporate all the changes brought with the ISO 14155:2011. To help you with this tedious exercise, WMDO has created the ISO 14155 Version 2003 vs. 2011 Gap Analysis that will clearly lead you through the hundreds of changes across more than 175 posts between the two documents. This comprehensive and valuable resource will help you save significant time and effort in completing the upgrade of your clinical quality system.
The ISO 14155 Version 2003 vs. 2011 Gap Analysis is available for free until March 31, 2011 to Premium account holders upon purchase of the 7 course suite ISO 14155: In Depth Review
This document is made available to Premium account holders only, who may purchase the Gap Analysis separately for €105.-
Buy Now
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