Senior Quality and Validation Engineer Mark Smith and Principal Electronics Engineer Angela Delbridge explain why K2’s status as a medical device manufacturer means its products lead the way and provide the most beneficial healthcare solutions on the market.
What do your roles involve?
Mark: I look after the scheduling, validation, and quality of the System products, which consists of combined software and clinical applications we deliver to our customers. My role is to ensure that the validation team are on track with the deliverable time requirements and ensure that all essential features and components are reviewed prior to their release to our customers. During this validation period we also produce documentation to ensure we record all data changes, ensuring we have an auditable trail on any change or implementation we produce, which complies with ISO13485.
Angela: In other words, it’s up to us to ensure we meet our regulatory obligations as a medical device manufacturer. Be that from the European Union or from the UK MHRA.
What does being a medical device manufacturer entail?
It involves extra levels of checks and controls throughout product design and development to ensure products are safe and deliver clinical benefits to patients.
What is important about K2 being a medical device manufacturer?
K2’s products, be they software or hardware, are CE marked as medical devices. This is an important sign of quality and safety for patients and users alike. Our products and internal procedures comply with internationally recognised safety standards.
What must you do in order to be a medical device manufacturer?
As a company to be a medical device manufacturer we must meet the European Commission’s Medical Device Directive/Regulation. Moving forwards, post-Brexit, we will also be complying with the UK Medical Devices Regulation and our products will show the new UKCA mark of safety in addition to the CE mark. In order to use these safety and conformity marks K2 must maintain an approved internal Quality Management System, and be audited by an independent Notified Body accordingly. The Notified Body may also review technical and clinical information related to our products and add their independent approval where appropriate.
How does this mean that K2 differs from our competitors?
K2 prides itself on the way we embrace our medical device regulatory responsibilities. Regulatory compliance is the cornerstone to patient safety and improving patient safety to achieve the best health outcomes is our overwhelming consideration. Our approach is not the easy path but it is a necessary one if we are to beneficially impact healthcare with our products. K2 leads the way.