Medical Devices

19
Oct

I Hear You – But Do I Understand You? Hearing Aids to Go OTC!

Tomorrow, FDA will issue a revised draft guidance on Hearing Aids and Personal Sound Amplification Products (PSAP) (here), and is also publishing a proposed rule for the over the counter (OTC) classification of hearing aids (HA) and PSAP (here) entitled “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids”.  These are the prepublication […]

Read More
25
Feb

Wrapping Up Medical Device Week

The week of February 1, 2021, Lachman Consultants held their inaugural Medical Device Week: A Lachman Learning Experience™. The week combined blogs and a webinar that touched on several different topics involving AI and diagnostics, data governance, SDLC infrastructure, change control, cybersecurity, as well as organizational maturity. Despite the name of the week, many of […]

Read More
05
Feb

Cybersecurity Must Be Offensively Proactive to Protect Your Assets

Interoperability in healthcare has been discussed for decades and is one the greatest challenges to be overcome in medicine.  Not only because technical barriers exist, but because physicians practice medicine and research continue to push the boundaries, creating new terms to be defined and understood.  In addition, the rate of this is accelerating (witness the […]

Read More
04
Feb

Don’t Reinvent the Wheel – Use Your SDLC Infrastructure to Manage Product Change Control

What engineer enjoys writing Software Development Life Cycle (SDLC) documents, such as a Software Requirements Specification or SFMEA?  I have yet to meet one that has the passion to sit and document the requirements. While there are numerous purposes and reasons for documenting the requirements, the greatest value is in the process that leads up […]

Read More
02
Feb

Medical Device and Drug Development and Manufacturing Data Governance in the Information Age

It is not uncommon for organizations to have different IT systems for regulatory, product, and organizational information.  Segregating the data, such as the QMS gate reviews, complaints, and adverse event reporting, from the product sales quota and organizational growth projections and actuals keeps regulatory auditors to the task at hand – inspecting the Quality Management […]

Read More
01
Feb

Using AI to Modernize Diagnostic Tools

Machine Learning (aka Artificial Intelligence) has put a spotlight on the importance of algorithms.  While the term algorithm is ancient, meaning “a process or set of rules to be followed in problem-solving operations,” the modern use within refers to the complex way that the software behaves. Before broad adoption of Machine Learning in other industries, […]

Read More
26
Jan

Webinar on FDA Incentives Features Compliance Expert

Next Wednesday’s free webinar from Lachman, “FDA Incentivizing Organizational Maturity to Drive Product Quality,” will be hosted by Lachman’s Vizma Carver, M.S. In this 90-minute session, she will dive in on the FDAs efforts to utilize incentives to drive product quality. As someone who used to work at the FDA, Ms. Carver is uniquely positioned […]

Read More
22
Jan

MEDICAL DEVICE WEEK – A LACHMAN LEARNING EXPERIENCE – FEATURES WEBINAR ON FDA QUALITY INCENTIVE PROGRAMS

The FDA is focused on evolving the medical device industry, ensuring safety, and enhancing quality among all manufacturers. Their goals are being met in part through two incentive programs – the Center for Devices and Radiological Health’s (CDRH) Case for Quality Voluntary Improvement Program (CFQ VIP) and the Center for Drug and Evaluation Research’s (CDER) […]

Read More
1 2 4