Medical Device Testing Laboratory
Astute lab offers medical device testing services. We are reputed as one of the most trusted medical device testing laboratories in India with a dual accreditation of NABL & CDSCO. We conduct tests as per IEC/EN & Particular Standards.
We can test products as per IEC/EN 60601-1, IEC/ EN 60601-1-2, IEC/ EN 60601-1-6, IEC/EN 60601-1-8 and Particular Standards. Our knowledge of products & standards translates to faster time-to-market for your next innovation.
Serving over 1000 clients in India and abroad
Our dedicated teams of experts have over 15 years of experience in a wide range of testing services & different categories of medical devices to help you meet medical device regulations and ensure that every aspect of your medical device is properly tested with reference to standard requirements.
At Astute we understand that you not only develop a great functional product, but you also need to demonstrate the compliance of your product with different standards suggested by the regulatory authorities. We manage our competency and capability so as to suit your regulatory compliance needs.
In-Vitro Diagnostics Equipment Testing
The In Vitro Diagnostics Directive (IVDD) 98/79/EC is a set of regulatory requirements that medical device manufacturers must comply with in order to place CE marking to their product for European market. As an IVD Notified Body, our team of specialists and technical experts can help you obtain IVDD compliance in order to get your devices to market.
In Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples, (e.g., blood, urine, and tissue that has been taken from the human body) in order to:market
> Help detect infection
> Diagnose a medical condition
> Prevent disease
> Monitor drug therapies
Devices can range from simple tests to sophisticated DNA technology including reagents, calibrators, control materials, kits, software, and related instruments. IVD is an important segment in the global healthcare industry. The marketplace is witnessing rapid growth fueled by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests. IVDs add significant value to treatment processes and medical diagnoses, enhancing the well-being of the general public. Our expertise translates to faster time-to-market for your creation.
We can test products as per IEC/ EN 61010-2-101, IEC/ EN 61326-2-6, IEC/ EN 62304, IEC/ EN 62366
Astute labs Pvt Ltd offer testing services for the medical devices as per ISO 10993 series of standards,
EN ISO 10993-5 In vitro cytotoxicity in L929
EN ISO 10993-10 Intracutaneous reaction in rabbits
EN ISO 10993-11 Systemic injection test in mice
EN ISO 10993-11 Systemic injection test in mice with polar and non-polar extract
EN ISO 10993-11 Systemic injection test in mice with polar and non-polar extract
EN ISO 10993-1 Mucous membrane irritation test with polar and non-polar extract
EN ISO 10993-10 Primary Skin Irritation test
EN ISO 10993-10 Mucous Membrane Irritation test
EN ISO 10993-6 Acute implantation test in rabbits
EN ISO 10993-6 Subacute implantation in rabbits…30 days
EN ISO 10993-6 Subacute implantation in rabbits …90 days
EN ISO 10993-10 Skin sensitization test with polar and non-polar extract in guinea pigs
EN ISO 10993-4 Hemocompatibility test
EN ISO 10993-10 Skin sensitization test in guinea pigs
EN ISO 10993-3 Genotoxicity Test option 1 of ISO 10993-3
– a) AME’S Test
– b) In Vitro Genotoxicity Test OECD 473
– c) In Vitro Genotoxicity Test OECD 476
EN ISO 11737-1 Bio Burden test
EN ISO 11737-1 Sterility test
EN ISO 10993 Part 10 Irritation
EN ISO 10993 Part 10 Intracutaneous reactivity
Biocompatibility Toxicology Tests
Packaging Validation Testing
At Astute labs we offer services of packaging validation which cover different tests like testing of packaging material, testing of packed medical device with drop tests & more. The aim is to simulate all the conditions of handling of the medical devices.
Accelerated Ageing Testing
Astute labs Pvt Ltd offers real-time and accelerated ageing study of the medical devices based on the shelf life of the product. The purpose of this test is to validate the different packaging types for the effectiveness. It includes Dimensional inspection, Functional inspection, Visual inspection and the tests related to packaging integrity.
Our Location:
Test House
Sr. No. 82/1, Bajirao Dhawade Patil Industrial Estate, NDA Road, Shivane, Pune-411023, Maharashtra, India
Corporate Office
Office # 01A, B Wing, Siddhesh Optimus, Opp. Lunkad Queensland, S. No. 211, Viman Nagar, Pune – 411014, Maharashtra, India.
For Enquiry: Medical Device & IT Testing
Phone: +91 9689944877
Phone: +91 7776992225
For Enquiry: Food & Water Testing
Phone: +91 7775891738
Phone: +91 7776992225
Email for all Enquiries: test@astute-labs.com