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March 2011

John E. Lincoln

Product Risk Management Under ISO 14971:2007 and ICH Q9

by John E. Lincoln
J.E. Lincoln and Associates LLC

Risk Management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

All medical interventions involve some level of risk, which is acknowledged on the FDA's website and within ISO 14971:2007 standards. The goal of the responsible manufacturer is to reduce product risk and to identify/know the levels of remaining risks, which are tied—ultimately—to a user's (clinician and patient) safety.

ISO 14971:2007 is the U.S. FDA's de facto standard for medical device risk management and ICH Q9 is a guidance for drugs. ISO 14971 is mandated under the European Commission's (EU) Medical Device Directive. Although each regulation is geared to its own industry, both should be considered collectively for the value they provide.

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FDA Announces 510(k) Changes

by MassDevice staff

The Food & Drug Administration announced that it plans to make 25 changes to its 510(k) medical device clearance program this year, but will hold off on any major moves until after the release of an Institute of Medicine report scheduled for the summer.

The watchdog agency's Center for Devices and Radiological Health said it would implement changes including the streamlining of the "de novo" review process for lower-risk devices, more clarity on when medical device manufacturers must submit clinical data in a 510(k) submission and the creation of a council to improve regulatory science.

Nearly half of the 55 changes the agency recommended in August 2010 were temporarily taken off the table. Among those were several of the most controversial elements, such as the ability to revoke 510(K) clearances, increased post-market surveillance and the establishment of a new classification for medical devices that would require the submission of clinical evidence.

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The path to market for software that is to be used with medical devices can be rigorous. According to FDA News, the FDA recently announced a "less burdensome path to market." Medical Device Data Systems (MDDS) (i.e, software and hardware combined) are now defined as low-risk devices or Class I devices.
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