Effective Collaboration with Testing and Certification Bodies
As today’s medical device industry continues to evolve, manufacturers are under increasing pressure to develop innovative products and technologies that not only meet changing healthcare and patient needs, but also comply with stringent regulatory and safety standards requirements. In order to navigate this complex environment, effective collaboration with testing and certification bodies has become critical to the overall success of product launches.
While this may seem daunting as a medical device manufacturer, I’ve assembled a list of ways to improve collaboration and strengthen the relationship between manufacturers and test providers.
Getting Involved Early
It can be tempting to wait until your product and documentation are perfected and ready to go before entering the test lab. However, early involvement can identify potential compliance issues or design challenges, saving time and money in the long run. Contact and involve your testing and certification partner at the beginning of the product development cycle. Intertek can provide initial design reviews, pre-testing, training and mentoring – all designed to make your testing and certification process run smoothly.
Open Communication
As with any relationship, starting with clear, open communication is always the first step to success. Whether discussing project timelines, potential challenges, or specific testing requirements, it’s critical to maintain an open dialogue in both directions. This ensures that both parties’ expectations and overall goals remain aligned.
Taking advantage of expertise
In addition to taking advantage of available resources, one of the best ways to work with a testing organisation is to leverage the expertise of its technical experts and staff. Testing and certification organisations such as Intertek have a wealth of knowledge and years of experience in medical device testing and certification. While manufacturers are always the experts on their products, Intertek has the ability to apply these standards and make them available for evaluation. Leveraging this expertise can provide manufacturers with insights beyond compliance, such as market trends and technological advances.
Make the most of your resources
Keeping up with changing standards, regulatory and compliance requirements, and global regulations that apply to medical devices and systems can feel like a full-time job. One way to ease this burden is to take advantage of available resources and leverage the thought leadership and educational information provided by testing organisations. Attending trainings, attending seminars, and reading webinars and thought leadership materials can all help you stay informed and stay current.
Regular reviews and feedback
Finally, one of the most important aspects of overall collaboration and communication between test labs and manufacturers is maintaining regular reviews and feedback. Constructive feedback can be a game changer. Whether it’s feedback on the testing process, the documentation and reference materials provided, or any number of other aspects, an ongoing feedback loop can help refine the process and achieve better results. Working together to establish a schedule of regular project reviews not only ensures that projects continue to be tracked, but it also provides opportunities to address issues and readjust strategies when needed.
In conclusion, the road to creating successful medical devices in today’s complex environment is paved through collaboration. By understanding each other’s strengths, leveraging existing knowledge and expertise, and maintaining open communication, manufacturers and testing organisations can work hand-in-hand to not only meet but exceed industry standards, ensuring that safe, compliant, and groundbreaking medical devices are delivered to the market.