The Secret to Success for Medical Device Manufacturers

Working Effectively with Testing and Certification Agencies With the ever-increasing pace of today's medical device industry, manufacturers are under growing pressure to develop innovative products and technologies that not only address evolving healthcare and patient needs, but also adhere to strict regulatory and safety standards requirements. To navigate this complex landscape, effective collaboration with testing and certification agencies becomes key to the overall success of a product launch. Although it can seem daunting as a medical device manufacturer, I've gathered a list of ways to improve collaboration and strengthen the relationship between a manufacturer and testing provider. Open Communication As with any relationship, starting with clear and open communication is always the first step to success. Whether discussing project timelines, potential challenges, or specific testing requirements, it's crucial to maintain a two-way open dialogue. This ensures both parties are aligned in their expectations and overall objectives. Early Engagement It can be tempting to wait until your product and documentation are perfect and ready-to-go before engaging with the test lab. However, early engagement can identify potential compliance issues or design challenges, saving both time and money in the long run. Reach out and involve your testing and certification partner at the onset of the product development cycle. Intertek can provide preliminary design reviews, pre-testing, training, and guidance – all to set you up for a smooth testing and certification process. Utilize Resources It can feel like a full-time job to keep up with the continuous changes in standards, regulatory and compliance requirements, and global regulations that apply to medical devices and systems. One way to lessen that burden is to utilize resources available and tap into the thought leadership and educational information provided by the test house. Engaging in trainings, attending workshop sessions, and consuming webinars and thought-leadership material can aid your understanding and help you stay up to date.

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The Secret to Success for Medical Device Manufacturers
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The Secret to Success for Medical Device Manufacturers