Continued innovation in the medical science and technical arena, increasingly improves our ability to enroll the right patient at the right time with the right therapy. Highly accurate diagnostics as well as new advances in the medical device space play pivotal roles in making this happen. Regulations and guidelines are progressing rapidly to reflect the need for the highest possible levels of accuracy, reliability, and human safety in all aspects of healthcare.
The new EU-Regulations on in-vitro diagnostic tests and medical devices demand the submission of high-quality documentation on the analytical and clinical performance of the device or diagnostic, manufacturing according to standardized systems, and the need to regulate surveillance safety and security after launch.
Innovators may not have the competencies or time to navigate through this complex labyrinth of regulations and requirements that appear ‘fragmented’ and are not globally harmonized. Many bottlenecks exist for companies that aspire to obtain market authorization for their products:
These and many other questions can be addressed. HALO Research Technology and its business partners provide Excellence in Regulatory Services, facilitates Access to Biological Samples, develops comprehensive business plans for Market Access, and acts as Authorized Representative for non-EU based companies through their office in the European Union.