Medical Investigations for Safety and Efficacy (MISE) - Unit
MISE Unit: VIVO BIO TECH’s specialized division for medical device testing and training. Established to enhance the medical device ecosystem both in India and globally, MISE is India’s first private-sector facility dedicated to medical device testing. The division operates under leading quality systems, including OECD GLP, ISO, AAALAC, and CDSCO certifications, and utilizes large animal models such as pigs, dogs, and sheep for testing.
Our Testing Capabilities and Services:
VIVO BIO TECH provides cutting-edge testing services for medical devices, strictly adhering to GLP and ISO standards. Our subject matter experts work with clients to design and recommend study protocols essential for device approval. With proficiency in ISO and FDA regulations, MISE offers robust preclinical testing services for medical devices across various fields, including:
Our facility is OECD GLP certified and ISO accredited, and our data is recognized by regulatory authorities such as USFDA (510K & PMA), EU (CE Marking), and others worldwide. We proudly serve clients from India, the USA, UK, France, Canada, Brazil, Malaysia, Germany, Australia, China, Norway, Saudi Arabia, Thailand, Indonesia, Switzerland, Japan, and beyond.
With a commitment to advancing medical device safety and efficacy, the MISE Unit at VIVO BIO TECH is your trusted partner for preclinical testing needs in line with global standards
Device-Specific Testing Solutions
Our laboratory is equipped for various device-specific testing needs, including but not limited to:
