A new year is a great time for new beginnings and to take a fresh look at things. 2016 is a truly exciting year for Protocol Link as it marks our 20th year in business. For the past 20 years, Protocol Link has strived to be our customer's choice and offers the best of both quality and efficiency for FDA-regulated companies. Along the way, we have accomplished many significant milestones that will remain with us forever. Success of our business depends not only in aligning with niche opportunities, but also in recognizing our true capabilities and bringing this expertise to our clients in their best interest.
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Protocol Link's
Device & Diagnostics Services
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Protocol Link is pleased to announce the launch of our Device and Diagnostics Services!
Device and diagnostics capabilities have always been at the core of our expertise. Since 1996 we have delivered numerous assignments within the scope of 21 CFR Part 820 and ISO 13485. Many of these represent our largest projects. On our 20th Anniversary, Protocol Link is pleased to announce the launch of the Device and Diagnostics Services package that showcases our capabilities and services! This launch is a result of extraordinary drive by dedicated and passionate members of the Protocol Link team that have demonstrated their understanding into aligning and articulating your need and want from a perspective of the device and diagnostic industry.
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For further information, call the Protocol Link Offices at 847-549-0390 or contact Christine Shumard-Sauer, Ph.D., Director, directly
via email to learn more.
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Upcoming Changes -
510(k) Device Modifications
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Christine Shumard-Sauer, Ph.D., Director
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 The medical device industry has long known that in order to innovate, modifications to a cleared device are often needed. What has been somewhat less clear is when those modifications require a new 510(k) submission.
Recently, FDA has been working with stakeholders, including the medical device industry and the public, to gather information on use of the guidance in order to ensure that patients have timely access to modified devices while balancing safety and effectiveness. The original guidance, When To Submit a 510(k) for a Change to an Existing Device, also known as K97, is under revision based on stakeholder input that was published as a report to Congress in 2014. The stakeholder input was gathered from industry, patient advocacy groups, and consumers, including discussion at a 2013 public hearing.
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Data Integrity -
Some More Discussion
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Daniel J. Hoch, Ph.D., Vice President
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 Industry has introduced the acronym "ALCOA". This acronym stands for
Attributable,
Legible,
Contemporaneous,
Original and
A
ccurate to provide attributes of data integrity. This term was later supplemented with "ALCOA+" which adds Complete, Consistent, Enduring and Available as four (4) additional attributes.
ALCOA+ attributes describe the desired state for original (raw) data collection and storage on a permanent medium. ALCOA+ assures that collected data is genuine and has an audit trail to expose any data changes to a reviewer. ALCOA+ permits people to return to that original data in the future and verify that correct decisions were made. Data integrity proves that the original value is trustworthy.
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One of our first device and diagnostics projects started in 1996, the year Protocol Link was founded. Year-over-year, the Device and Diagnostics Service has consistently represented a significant portion of our business. Over the past 20 years, we have delivered dozens of such assignments. I am excited about having a stand-alone set of collateral in the device and diagnostics space. This sector fits very well with our services and capabilities. THANK YOU Chris and Bryn in making this happen and to the rest of our core team for contributing, guiding, navigating, and helping them make this run through the finish line! |
Congratulations!
Dipak Doshi
Chief Executive Officer
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From our experiences, companies that have integrated their quality systems globally from top-down have generally shown a huge advantage in ongoing process effectiveness and GMP compliance vs. their competition. This includes ensuring that inputs from regional sites are actively sought and incorporated routinely. It is difficult to expect true ownership and accountability from operating units disconnected from the process of setting system policies and performance criteria.
Ensure your global Quality Plan clearly communicates to each operating entity all fundamental elements of the Quality System which must be in place, including the associated performance and compliance expectations. Refine this Plan annually as a priority. Structural consistency will link each operating entity from the start, encourage the sharing of best practices, strengthen site-to-site communications, and firm up GMP compliance demonstrably over time.
Global integration of your quality system requires a major investment but the positive business returns are worth the cost.
Steve Weltler
President
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STAY CONNECTED WITH PROTOCOL LINK
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