Articles & Whitepapers

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A Four-Tiered Approach to Comprehensive Complaint Handling Integrated with CAPA,
a guidance document by Kevin Randall, RAC (U.S., EU, CAN)

Decoding 21 CFR 820.198 – An integrative practical model clarifying the four tiers of FDA complaint handling requirements integrated with risk management and CAPA.

Venture Capitalist Medical Device Development: Maximizing ROI in an FDA-Regulated Environment, by Kevin Randall, RAC (U.S., EU, CAN)

Infusing the business plan with strategic regulatory tactics early on during product development is essential to maximize commercial value of high-risk (i.e., life supporting/sustaining) medical devices regulated by the U.S. Food and Drug Administration (FDA). This article presents an actual venture capital medical device development project (names and details have been changed for confidentiality) and demonstrates the integration of strategic regulatory tactics at k ey project milestones.

A GMP Compliance Blueprint for Outsourced Medical Device Manufacturing by Kevin Randall, RAC (U.S., EU, CAN) – Published in March 2008 issue of MD&DI Magazine

Clearly there are many domestic and foreign firms outsourcing the fabrication of their devices destined for the U.S. market. Properly managing current Good Manufacturing Practice (GMP) issues is a critical part of any successful outsourcing business endeavor. Yet pinpointing the applicable GMP obligations can be tricky. Every outsourcing scenario has unique aspects that impact Stakeholder GMP responsibilities. This article suggests a blueprint intended for use as a launch pad to help readers tailor a customized GMP strategy to meet the needs of their own unique outsourcing situation.

A Practical Overview of FDA’s Design Control Requirements
by Kevin Randall, RAC (U.S., EU, CAN)

For more than twenty years, the U.S. Food and Drug Administration (FDA) has identified insufficient design controls as a major factor in product recalls. In 1990 FDA published a study based on 5 years of recall data showing that 48-90% of all recalls were due to deficiencies designed into the product. This article presents a model discussing the practical considerations of an effective design control system.

Validation of Analytical Test Methods in Medical Device Manufacturing
a guidance document by Kevin Randall, RAC (U.S., EU, CAN)

The U.S. Food and Drug Administration’s (FDA’s) Quality System Regulation is essentially silent on validation of test methods when applied during medical device manufacturing. Yet firms continue to be cited by FDA in relation to 21 CFR 820.75 (process validation) when test methods are not validated. No specific guidance is available from FDA addressing general validation of test methods in the medical device industry. In this article, test method validation principles have been adapted from pharmaceutical industry guidance provided by FDA and the International Conference on Harmonization (ICH) since validation of analytical test methods in the drug industry is a well established practice.


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