Medical Device 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. Partnering with Doshaheen Solutions will ensure that this part of your project runs efficiently and smoothly. Our technicians are frequently devising sophisticated protocols under pressure, and they are fully resourced to ensure rapid delivery of test work. We cannot guarantee what the results will be or shorten the dwell time in a test, but we can ensure accuracy and efficiency.

Partner with Doshaheen for your medical device testing and we promise:

• Rapid and competitive quotations
• Rapid project commencement
• Rapid access to equipment
• Efficient delivery and reporting

We work to ISO 17025, CGMP, HIPAA, PHI, e-PGI regulations and compliances. Have extensively worked with Class 1 & Class 2 categories of medical devices and related software. We understand the regulation and process of 510(k) submission. We are also aware of PMA process and our V&V strategy is built around these. Hence we have worked on 21 CFR Part 814 and understand it thoroughly. We understand IDE and have used this for devices under investigational use for our V&V activity.

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.

We Know Medical Devices

Doshaheen is supporting medical device companies across the globe, having conducted thousands of hours of testing on a broad range of devices. We know how to apply risk analysis to your product and apply the result to deliver a fast, cost-effective design validation and verification service.

You benefit from this inside knowledge, which is informed by extensive testing experience with all classes of device and in many applications.