How do you know you are ready for preclinical work? Insights and recording from our latest webinar.

How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg joined Renovo Biomedical’s Anna Fallon on January 14, 2021 to answer that question.

How does our verification and validation phase of medtech development ‘translate’ to preclinical studies?

In section 21 CFR 820.3 of the federal code, FDA defines design verification as “the process of confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Design validation is defined as “the process of establishing by objective evidence that product specifications conform with user needs and intended use(s).”  Medical product…

How do you know you are ready for preclinical work? Join us for a free webinar on January 14.

Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions.  But this type of work is also expensive. The most effective product development strategies use preclinical studies wisely. The most expensive preclinical study is the one you have to repeat.   How…

ALung Technologies granted Emergency Use Authorization by the FDA for their Hemolung® Respiratory Assist System for the Treatment of COVID-19

A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung® Respiratory Assist System (RAS), the world’s first fully-integrated respiratory dialysis system. This system removes carbon dioxide directly from the blood, allowing the patient’s lungs to rest and heal while avoiding…

Behind the scenes: what it takes to keep an industry leading preclinical CRO running right

GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards  for our medtech and life science customers. …

Free webcast: Importance of gross pathology and histopathology in a preclinical study

Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols…

“What makes a high quality preclinical study final report?” – FREE Webcast

The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not the only study that a reviewer might be working on. How do you make the report detailed, yet easy to read? What elements must be present? What common mistakes should you be certain to avoid?…

Buyer beware: Common costs in preclinical research: a free webinar from GCMI

All preclinical study estimates are not created equal: they may or may not include line items that can widely influence the total fee. We know preclinical studies are expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but is not always…