Articles & Resources

Regulatory

Below is a collection of articles, resources and stories from the Invetech team and industry experts, sharing their knowledge, experiences and advice on product development and market trends.

Regulatory

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How COVID is Accelerating Multi-Drug Resistant Infections with Selux Dx

In this episode of Spilling the Tea, we talk with Steve Lufkin of Selux Diagnostics about building a company culture during a pandemic, changes in the antibiotic susceptibility testing (AST) market and the current fundraising environment.

The Future of Complex POC Tests with MDC Associates

In the first episode of our new “Spilling the Tea” interview series, we talk with Joen Johansen of MDC Associates about government and private partnerships and the future of complex POC tests.

Emergency Use Authorization: How IVD Developers Can Use the EUA to Address COVID-19

Watch our interview with Fran White of MDC Associates on using the EUA for COVID-19 testing to fast track approval, what’s required by the FDA and how to plan for an eventual 510(k).

Achieving CLIA Waiver – Designing for Simplicity

As demand for POC diagnostic platforms continues to grow, product development to achieve CLIA waiver is becoming increasingly necessary for IVD manufacturers.

The Evolving Regulatory Climate for Cell & Advanced Therapies

Invetech invited experts in regulatory affairs to share their insights and offer guidance on how to keep clinical development programs moving forward.

Cybersecurity for Diagnostic Devices

The interconnectivity of diagnostic technology will revolutionize healthcare, but will also bring significant risk. Joshua Anderson describes how to prevent it.

RoHS 2 and IVD: Are You Ready for the Deadline?

Compliance with the new RoHS 2 regulations will be mandatory by July 22, 2016. Ian Sellars is here to explain the details.

Improving Design to Ensure Safe, User-Friendly Medical Devices

Alan Morris and Andreas Knaack of Invetech go into the details of what makes great products just so great.