Medical Device Testing: Trusted Service Provider

Are You Looking For Medical Devices Certifications?

Looking for Regulatory Consultant ?

As we rely on the proficiency of the medical device to perform as intended, the slightest deficiency in the medical device can provide tragic results.

Medical device testing evaluates various aspects of the medical devices to block the usage of defective devices on patients. Medical device testing also demonstrates that the medical device is safe and reliable to use. In short Medical device, testing indicates Medical device is certified to perform as per intended use. Medical device testing facilitates you to provide evidence of its compliance with standards and regulations around the globe.

Medical device testing includes:

Performance testing
Bio-compatibility testing’s
Clinical and pre-clinical testing’s
Chemical Analysis
Quality Assurance testing (Dimensional check and functional testing’s)

Medical Device Testing Services

The test requirements for each type of medical device are different. These testing requirements are in turn based on the material, manufacturing process of medical devices, applicable standards, and regulations.
We advise you on what testing are to be carried out on your Medical device. We assist you to co-ordinate with the accredited lab to execute the testing.

Medical Device Testing Laboratories

There are numerous labs available that provide testing for a wide range of the medical devices. The labs are selected based on the certifications it has. The testing protocol and report content used by the lab shall be approved by notifying bodies. The labs shall be ISO 17025 accredited. Various tests require the labs to be GLP certified.

Medical Device expertise

We guide you on selecting the appropriate labs based on the requirements of your Medical device testing.

We interpret the test standards and guidelines to determine the test requirements and adequate test methods to be used for your device. We help you determine test parameters and acceptance criteria.

FAQ:

The general standard that is not specific to the medical device includes packaging ISO 11607, toxicity ISO 10993, IEC 62366.

It is a regulatory requirement ensuring that the device is compatible with the biological system where it will use.

Medical device testing is crucial for CE certification because it verifies that the device performs safely and effectively as intended. Testing provides evidence that the device meets the required standards and regulatory requirements under the EU Medical Device Regulation (MDR). It helps identify any defects or risks, ensuring only safe, reliable, and compliant devices reach patients. Accredited labs conduct these tests following strict protocols, and their reports are essential for demonstrating conformity to notified bodies, which is mandatory for obtaining the CE mark. Without proper testing, the certification process cannot confirm that the device is suitable for market release.

Type testing in medical devices refers to a series of standardised tests performed on a specific model or design of a medical device to verify that it meets required safety, performance, and regulatory standards. It ensures that the device consistently performs as intended and is safe for use before it is released to the market or used on patients. These tests assess various aspects such as functionality, biocompatibility, chemical safety, and durability, based on the device’s material, manufacturing process, and applicable regulations. Type testing is conducted by accredited laboratories following approved protocols, and provides documented evidence of the device’s compliance with global standards.

Maven offers guidance throughout the medical device testing process. We help identify the specific testing requirements based on your device’s material, manufacturing process, and applicable standards and regulations. We advise on the appropriate tests needed, such as performance testing, biocompatibility, clinical and pre-clinical testing, chemical analysis, and quality assurance checks.

Additionally, we assist in coordinating with accredited testing laboratories that comply with international standards like ISO 17025 and GLP certification. We ensure that the labs follow approved testing protocols and provide compliant test reports.

With our expertise, we interpret test standards and guidelines, define suitable test methods, parameters, and acceptance criteria tailored to your device.

Medical Device Testing

Medical Device Testing Services

Medical Device Testing Laboratories

Medical Device expertise

FAQ:

Our Blogs

Risk Management in Medical Device Development: Key Strategies and Systems

Medical Device Labeling Compliance: How to Avoid Regulatory Pitfalls

Regulatory Innovations for Aseptic Processing: Adapting to Evolving Standards

CE CERTIFICATION CONSULTANCY FOR MEDICAL DEVICE

CDSCO APPROVALS FOR MEDICAL DEVICES

US FDA 510(k) APPROVAL CONSULTANCY

UKCA CERTIFICATION REGULATORY CONSULTANCY

OTHER REGULATORY CONSULTANCY

Medical Device Testing

Medical Device Testing Services

Medical Device Testing Laboratories

Medical Device expertise

FAQ:

1.What are the testing standards to which the medical devices should comply?

2.Why is Bio-compatibility testing performed for medical devices?

3.Why is medical device testing important for CE certification?

4.What is type testing in medical devices?

5.How can Maven assist with medical device testing?

Our Blogs

Risk Management in Medical Device Development: Key Strategies and Systems

Medical Device Labeling Compliance: How to Avoid Regulatory Pitfalls

Regulatory Innovations for Aseptic Processing: Adapting to Evolving Standards