Lab developed tests and FDA regulations in the IVD market
Today there is much discussion on the Food and Drug Administration (FDA) regulation and oversight of Laboratory Developed Tests (LDTs). The debate features numerous topics including the necessity for regulation, whether the FDA has the authority to regulate, the feasibility of the proposed regulations, and the effect on innovation if indeed regulation is put into place.
IVD instrument development with an OEM partner: Six essential elements for success
You have made the decision to enter into the development of an IVD system solution for your customers. You have learned that inviting an OEM partner into your project could be beneficial to reduce risks and fill expertise or skill gaps, but you are still hesitant. What are the key elements that you should consider to ensure the success of the collaboration?
Reducing risks in IVD instrument development
The In Vitro Diagnostic (IVD) medical device market is one where new and advanced applications are appearing every day. Equipment expertise and regulations are becoming increasingly complex to the point that a diagnostic company may not be able to keep pace and bring their platform solution to market in a timely manner with the appropriate support level required by the customer.
OEM Lecture Series
Reduce your time to market with your next liquid handling instrument development project.
Tuesday 2 August 11am , Theater 2
In a fast paced industry, we are constantly challenged to shorten development cycles. This lecture will offer ways to reduce timelines by effectively developing requirements, and selecting already available technologies and/or services.
- How to develop effective requirements.
- How to overcome the challenges that instrument developers are facing.
- How the Cavro Omni Robot will increase your project efficiency.