Medical Devices

26
Oct

Data Integrity Series: Episode 6

Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]

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18
Oct

Data Integrity Series: Episode 5

A strong organizational culture is essential for maintaining the quality and integrity of your company’s data. Does your company have a data-integrity-centric culture? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no […]

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26
Sep

Data Integrity Series: Episode 4

Episode #4 of our six-part Data Integrity video series focuses on Systems and Processes, two more essential elements for minimizing and eliminating data integrity issues. The video explains the four key points of Systems and Processes necessary for establishing a world-class data integrity program and the two primary controls that well-established Systems and Processes provide. […]

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08
Sep

Data Integrity Series: Episode 3

Our latest video in the Lachman Consultants Data Integrity Series, “People and Organization – The First Essential Elements of a World-Class Data Integrity Program” reveals how good people and organization practices can have a most pronounced impact on reducing your overall data integrity risk. How well is your company incorporating people and organization into its […]

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10
Aug

Data Integrity Series: Episode 2

Traditionally, data integrity programs have focused on electronic systems, but to keep pace with the industry, your company must evolve. Achieving digital maturity requires companies to develop a multi-dimensional program of governance for their data. Learn what a well-conceived program that achieves lasting data integrity consists of. “The primary purpose of this message is solely […]

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06
Jun

FDA Withdraws Covid Q&A Document as the FDA Returns to a Semblance of Normalcy

In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]

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03
Jun

Data Integrity Series: Episode 1

FDA warning letters have doubled since 2015 and more than 50% of observations involve data integrity. Fines up to $1 million per incident are possible. Get prepared and avoid the fines. “The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no liability for the accuracy and completeness […]

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20
May

Are You Ready for EU MDR? Only 24 Months to Go!

At the MedTech Forum 2022 in Barcelona, there was a tense and “standing room only” moderated session on the looming May 26, 2024 EU Medical Device Regulations (MDR) implementation deadline.  Representatives from the notified bodies, competent authorities, industry, and other trade groups had a very intense interchange about the deadline, which requires all companies selling […]

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09
May
Law and justice concept

Is Help on the Way? Contrast Agents and Drug Device Conundrum May Be Legislated Away

In a previous blog post (here), we discussed the results of an April 16, 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit in Genus Med. Techs., LLC v. FDA, 2021 (U.S. App. Lexis 10928 [April 16, 2021]) which the FDA decided not to appeal.  This court decision dealt with […]

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