BSI Healthcare Releases White Paper Describing How Recent EU Guidance Revisions Will Affect Medical Device Post-Market Clinical Planning

News provided by

Jun 06, 2012, 01:35 ET

RESTON, Va., June 6, 2012 /PRNewswire/ -- BSI Group America, Inc. has released a white paper entitled, The Post-Market Priority Understanding and Meeting Demand for Effective Post-Market Clinical Follow-Up.

(Logo: http://photos.prnewswire.com/prnh/20110405/NE77664LOGO)

The white paper examines how recent European Commission revisions to the post-market clinical follow up (PMCF) study guidance document (MEDDEV 2.12-2, REV. 2) will affect post-market clinical planning and the working relationship between medical device manufacturers and Notified Bodies.

The paper, authored by Dr. Hamish Forster, BSI Healthcare Solution's Orthopedic & Dental Product Expert, expands on a paper he recently published—Basic Anatomy of a Design Dossier—that provides an overview of the key elements required within technical documentation to demonstrate conformity to the Medical Device Directive 93/42/EEC.

The Post Market Priority underscores changes in the revision that reflect an emphasis on long-term clinical data and articulates the importance of the details and documentation required for post-market clinical studies as a part of an appropriate PMCF plan.

"With a more comprehensive understanding of these revisions," writes Dr. Forster, "manufacturers can work more efficiently and seamlessly with Notified Bodies in the review/audit process and plan and execute the PMCF plan, as well as overall post-market surveillance."

To download a copy of the white paper click here: www.bsiamerica.com/BSIpostmarketpaper

About BSI
BSI (British Standards Institution) is a global organization that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world's first National Standards Body and a founding member of the International Organization of Standardization (ISO). Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, reduce risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Famed for its marks of excellence including the instantly recognisable Kitemark®, BSI's influence spans multiple sectors including aerospace, construction, energy, engineering, finance, healthcare, IT and retail. With over 64,000 clients in 147 countries, BSI is an organization whose standards inspire excellence across the globe. To learn more, please visit www.bsigroup.com

About BSI Healthcare Solutions
BSI Healthcare's mission is to ensure patient safety while supporting timely access to global medical device technology. We provide thorough, responsive, predictable conformity assessments, evaluations and certifications that are recognized and accepted worldwide. To learn more, please visit www.bsiamerica.com/healthcare

Media Contact for BSI:
Shereen Abuzobaa
VP Marketing & Training
703-464-1931

SOURCE BSI