Cognition® Corporation Releases Second Paper on ISO 13485

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New installment of white paper series looks at FDA’s Design Controls and the quality management standard.

Cognition Corporation: How ISO 13485:2016 Will Impact Your Medical Device Development - Part 2
"Now that the transition period from the 2003 version to this current iteration has ended, we can anticipate FDA ramping up their efforts to harmonize their QSR with the standard in the near future."

Cognition Corporation, a software company specializing in medical device compliance and commercialization, has just released the second installment of their two-part white paper series discussing ISO 13485:2016, the quality management system (QMS) standard for medical devices.

The new white paper reviews some of the high-level changes to the standard identified in the first part of the white paper series in comparison to 21 CFR 820.30, FDA’s Design Controls Regulation.

“Medical device manufacturers in compliance with ISO 13485 should now be aligned with the 2016 version,” says David Cronin, CEO of Cognition Corporation. “Now that this is the case, our goal with this new white paper series is to look at how that alignment will impact FDA’s Quality System Regulation (QSR).”

Effective starting March 2019, medical device manufacturers aligned with ISO 13485:2016 will now officially be recognized. Now that this deadline has passed, FDA intends to begin harmonizing their QSR with the standard. This new installment of the white paper series looks at that harmonization in context with FDA’s Design Controls requirements.

“FDA has committed to adopting ISO 13485:2016 as the basis for its regulatory requirements for quality systems,” says Mr. Cronin. “Now that the transition period from the 2003 version to this current iteration has ended, we can anticipate FDA ramping up their efforts to harmonize their QSR with the standard in the near future."

This white paper takes a narrow look at the differences between Design Controls as outlined in FDA regulation and ISO 13485. By evaluating where they are alike and how they differ, the paper discusses what potential changes manufacturers submitting to FDA could see to existing Design Controls regulation as harmonization comes into full swing.

“Shifting to a new compliance scheme—especially when it comes to Design Controls—is no easy task,” adds Mr. Cronin. “Hopefully, manufacturers can use this paper to better address any current and future work to align with regulatory requirements and expectations.”

The white paper is available for download here.

Cognition Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition offers the Cognition Cockpit® Platform, along with engineering and validation support, and industry expertise. Thousands of users worldwide use Cognition solutions to manage their product development process and meet regulatory, performance, and time-to-market goals. For more information, visit http://www.cognition.us or call (781) 271-9300.

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Alex Critch
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