Medical Device Function and Performance Testing

Medical Device Function and Performance Testing

Meeting regulatory requirements in the varied world of medical devices requires deft project management. This can be a difficult and complex job. You have to balance the needs of a lot of different parties whilst staying within budget and holding to tight deadlines. The clinical needs and safety of the device are paramount and must be demonstrated.  

Rapid and competitive quotations

Rapid project commencement

Rapid access to equipment

Efficient delivery and reporting

We work to ISO 17025 and GMP. Once a contract is in place (purchase order, statement of work or technical agreement) we will respond with a protocol for your approval or comment within days.

Medical device testing is the process of demonstrating that the device will reliably and safely perform in use. In new product development, extensive Design Validation Testing is applied. This includes performance testing, toxicity and chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This will usually include dimensional checks, some functional tests, and packaging verification.

Performance Testing

Our laboratory has vast experience dealing with a wide variety of medical devices, from surface contact to permanent implants as well as with drug delivery products from auto-injectors to sprays and creams. Laboratory Testing- read more…

Materials Testing

Material characterisation has many applications in medical device development and production. It is the chemical analysis of materials to identify a ’finger print’. This information is then used to minimise toxicological testing of new designs as well as for production and design changes. Chemical identification should also be applied to incoming raw materials and on lot to lot production.  

Biocompatibility Testing

Medical devices require varying degrees of biocompatibility testing, according to their classification. The main source of guidance on the essential requirements for biological safety is ISO 10993 – Biological evaluation of medical devices. This standard defines devices in terms of their invasiveness and the duration of patient contact, which subsequently determines what level of safety testing manufacturers need to successfully complete prior to putting their device on the market. Safety Testing- read more…

First Line QA

Are product complaints diverting manpower and consuming resources you would rather spend elsewhere? Customer returns are an inevitable part of the business, but they need not be an integral part of yours! Our unique First Line QA service makes it easy to comply with the EU MEDDEV 2.12-1 Rev 5 “Guidelines on a medical device vigilance system” stipulating that “any manufacturer selling on the European market should make sure that their vigilance. Complaints Analysis- read more…

Medical Device Testing

On May 26, 2021, the Medical Device Directive (MDD) was replaced by the new Medical Device Regulation (MDR). The MDR is intended to be an improved version of the MDD, with the main difference being that the MDR, as a regulation, requires direct implementation in all EU member states. This allows the MDR to create a uniform and fair regulation for all member states and raise standards for quality and safety measures.

Not only will the MDR extend to all EU member states, but the guidance it provides will also encourage companies to act and improve their current product hygiene and safety, which should significantly improve their overall standards.

The regulation’s provisions require companies to review their portfolios and make the necessary changes to comply with the regulations.

Medical devices are subject to several regulatory requirements to protect the health of users, patients and third parties.

We have listed the most important requirements here:

Proof of a dedicated test plan according to DIN EN ISO 14155

Proof of the safety of the product in question

Approval of the competent higher federal authority BfArM (§ 22a MPG)

Approval by the ethics committee

Information and consent of the patient

Conclusion of a proband insurance

In the United States, the FDA’s Center of Devices and Radiological Health (CDRH) is responsible for regulating medical devices created and sold in the United States.

Medical devices in the United States are defines by classes (I, II, and III). These classes determine what regulation requirements the device or technology is required to follow. All manufacturers and distributers must register with FDA between October 1st and December 31st. When you register your medical device you must list all companies involved with the creation of the product, this includes packagers, manufacturers, labelers, developers, and sterilizers.

Depending on which class your medical device is, you will be required to submit a premarket notification along with other regulations such as PMA review and a third party review.

In the United States, any incident where a medical device caused or contributed to the injury or death of a person is required to be reported to the FDA. Any and all malfunctions must be reported so that they may be corrected.

Complete guide to software testing in the medical device industry

 

The U.S. Food and Drug Administration (FDA) has several regulations that specifically address software testing for medical devices. These regulations ensure that medical device software is safe, effective, and reliable, and the results are generally submitted to the agency.

One important regulation is the FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This guidance outlines the information that should be included in premarket submissions for medical device software, including details on the software’s intended use, device hazard analysis, and testing protocols.

Another key regulation is the FDA’s General Principles of Software Validation, which provides guidance on validating software for use in medical devices. The regulation covers topics such as the software development life cycle, documentation, and testing methods.

In addition to these regulations, the FDA has specific guidance on software changes to existing medical devices. This guidance outlines the processes that medical device manufacturers should follow when making changes to software that is already on the market.

With a proactive attitude, the company focuses on the interests of customers, continuously improves products to meet customer needs, and further pays attention to safety, reliability, environmental protection requirements and innovation of Penetrability Tester,Needle Penetration Test Method,Medical Product Testing Instruments Manufacturer,Medical Device Tester,Tensile Tester Manufacturer,Manual Carbonation Tester,CO2 Volume Tester,Medical Needle Puncture Tester,Melt Flow Index Tester Price,Horizontal Tensile Tester Supplier,Motorized Cap Torque Tester,Torque Testing Machine