Assessment of Product Specific Standards

A correct implementation of product specific standards is key to the development of safe and compliant medical devices. At Technolution, our Design Control team can help your organization understand existing and new product specific standards and their implications for your medical device. We can help assess the differences introduced by updates to existing standards or to implement new product specific standards in relation to requirements, product risk assessment and design implications.

Our services within product specific standards include:

1. Provide guidance on implementation
A core capability of our team is reading through product specific standards and providing your organization with guidance on how to implement a product specific standard in device design. We can also assist with documentation and test procedures for device features and functionality that deviate from the product specific standard.

2. Conduct gap analysis between new and previous version
When two versions of a product specific standard differ, we can assess the differences through a gap analysis.

3. Assist with developing new test procedures in collaboration with test and verification team

We can help your organization create protocols for testing and documenting a medical device’s compliance with a product specific standard.