The Medical Device Regulation (MDR) has ushered in a new era of stringent requirements for medical device manufacturers, especially regarding biocompatibility testing. Ensuring that devices are compatible with the human body is crucial, yet navigating the complex landscape of biocompatibility requirements, standards, and testing methods can be a daunting task.
Interlinked (formerly known as Tada Group) is an innovation-focused medical device company founded in 2016, aiming to serve previously unmet needs in the healthcare sector. Their first product, an advanced breakaway connector for IV lines called ReLink, was developed to make IV therapy safer and more efficient in human and animal healthcare. To ensure the product’s regulatory compliance and successful entry into the EU market, Interlinked partnered with Measurlabs for comprehensive biocompatibility testing by MDR requirements.
Expert support made MDR submission effortless for a small team
Interlinked turned to Measurlabs in the run-up to their MDR submission and product launch. With the help of Measurlabs’ experts, the testing plan for the IV connectors was actualized, taking into account the device's indirect contact with the patient’s body. In addition to the basic biocompatibility assessment endpoints of cytotoxicity, sensitization, and irritation, the connectors required pyrogenicity and hemocompatibility testing and an extended toxicological risk assessment to evaluate extractable and leachable chemicals.
“Measurlabs’ expertise was truly indispensable throughout the project. We are a small team with limited resources, and being able to get all the tests and risk assessments right on the first go made the whole MDR submission process very easy for us,” says Interlinked’s COO Rebecca Stjernberg Bejhed.
Saving precious time for product development
After previous experiences working with multiple consultants and laboratories, Interlinked soon found the value of collaborating with Measurlabs indisputable. With a single point of contact for all testing needs, they could streamline communication and minimize the burden on their internal resources.
“Working with such a responsive expert team has been like having an extra colleague – you can always ask them for advice if you feel unsure about something, and trust to get a reply quickly,” Stjernberg Bejhed remarks.
Receiving proactive expert support in both R&D and compliance testing has allowed Interlinked to focus on development work while still feeling confident that their products meet all quality and safety standards.
"With the reassurance we get from Measurlabs’ medical device experts, we can feel confident about moving forward with our product development and product launches,” Stjernberg Bejhed comments, and continues. “Their service has freed up a significant amount of time that we can use to develop the next innovative product to follow up on the success of ReLink.”