Worthwhile Due Diligence: Understanding the Technical Assessment of Your Technology

If you operate in the world of health technology, you’re probably familiar with the process of health technology assessments. A critical part of medical device investment, health technology assessments evaluate the various effects, properties, and impacts of health technology. 

This essential process is required to measure the economic, organizational, and social issues associated with health technologies like medical devices. In so doing, they inform policy decision-making and help the industry move forward as a whole. 

The Importance of Regulation

In the medical device industry, regulation reigns supreme. Just this year, the medical device regulation standard shifted to improve industry requirements and change the face of regulation forever. The updated guidelines released state that some medical devices now require reassessment to guarantee they meet the new regulatory standards. Under the new guidelines, some equipment that was already self-certified will be required to undergo resubmission to verify that they meet all regulatory requirements.

So why does this matter when it comes to your medical device?

First, technology has moved in leaps and bounds over the last decade. This, in turn, has changed the face of the medical device industry. As technology has evolved, regulations have been forced to do the same to keep up. Today’s regulatory changes aim to limit unreasonable constraints on the use of technology while also prioritizing the safety of users and devices alike. A good medical device will work well at its core for years to come and regulations can help those in the medical field make the most of previous technological advancements that have already done so much. 

Best Practices for Technical Assessments

Before undergoing technical assessments, there are a few best practices to be aware of. These include the following:

  • Send a complete submission. Incomplete submissions are one of the most common reasons for delays in assessment and certification. To make the process as efficient as possible, ensure your submission is complete before you deliver it.
  • Format your information correctly. There are a variety of format and file size limits, as well as requirements for bookmarks and signatures associated with assessments. Make sure you’re meeting the requirements set for each of these specified areas to avoid delays in your application. 
  • Work with a professional. Since the landscape of technical assessment is changing so rapidly, it’s essential to work with a medical device design team that understands the ins and outs of the development process, from beginning to end. Not only does this cut down on delays, but it also helps you make a smart medical device investment.

Medical Device Investment Partnerships

In the coming years, the demands on manufacturers will continue to change. We expect to see shifts in clinical and technical documentation, in addition to systems and implementation requirements. Although this is the nature of the industry, it does mean that people interested in making medical device investments will benefit from smart partnerships. This way, they’ll always be up-to-date with what’s new and won’t miss anything in the process. A medical device development partner will not only help you navigate the new regulatory and assessment environment, but also minimize delays, streamline your assessment process, and experience a smoother path to a successful launch. Take the first step toward your medical device development journey by scheduling a free consultation with our team of experts today.

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