Keeping Compliance on Track Through Testing.

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Author: Sandi Schaible
Date: May 2020
From: Medical Product Outsourcing(Vol. 18, Issue 4)
Publisher: Rodman Publishing
Document Type: Article
Length: 1,330 words
Lexile Measure: 1310L

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The beginning of 2020 has left the industry strained and delayed implementation of the Medical Device Regulation (MDR) by one year (May 2021). Regardless of where a manufacturer's product portfolio currently stands, challenges such as fewer notified bodies (NB) than anticipated and industry-wide capacity issues are prompting companies to push forward with their remaining compliance efforts. While much is out of the manufacturer's hands, one factor they can control is re-evaluating their testing plans. Now is the time to ensure these plans are as efficient as possible.

Testing Plan Evaluation

Committing time to review testing plans can help companies increase efficiencies and identify potential risks that could eventually delay approval. There are several factors medtech firms should consider when evaluating their current and future testing efforts, from the internal team and risk management to lab partnerships. Reviewing these areas can help ensure the timely success of testing plans.

Step 1: Assemble a capable team. Eliminating any room for error in a testing plan requires the support of the best possible team.Ihe internal team needs to know every detail about the product (s). A team with cross-functional knowledge spanning marketing, R&D, operations, and quality helps to ensure each testing plan is comprehensive and considers all angles. A strong team can also confirm all information is provided to the lab accurately and promptly.

A team with detailed product knowledge can support submission success from start to finish. For example, if a test returns with the device reporting higher levels of ethylene oxide residue than deemed acceptable for pediatric use, an informed product manager can provide necessary insight on the next steps. For a product not intended for pediatric use, these results would not be relevant. Without someone on the team to support this, further measures may have been taken, or even additional, unnecessary testing could occur, setting the timeline back and wasting money, The right team can streamline the testing plan with detailed knowledge of significant product markets and more.

Additional roles to involve...

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Gale Document Number: GALE|A623926223