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5 Signs That it is Time to Hire a Regulatory Affairs Expert for Your Medical Device Startup

July 24, 2023


Are you an entrepreneur looking to bring a medical device to market? As exciting as it may be, the process can quickly become overwhelming, especially when navigating regulatory requirements. That's why we're reviewing the signs that indicate it is time for your startup to hire a regulatory affairs expert. From streamlining the FDA clearance or approval process to ensuring compliance with regulations, these professionals have the knowledge and skills needed to help you navigate the regulations and get your product through FDA review. Keep reading to learn more about when it is time to hire a regulatory affairs expert and how they can help your team achieve their business goals.


What is a Regulatory Affairs Expert?

When you’re developing a new medical device, it’s important to consider the regulatory landscape. A regulatory affairs expert can help you navigate the process of getting your device cleared or approved by FDA so you can legally market your device. They can also help you develop a regulatory strategy for each market you intend to commercialize your device, to ensure that your device meets all relevant regulations. A regulatory expert can help guide you through FDA regulations and guidance documents and serve as a liaison between your company and health authorities.


If you’re not sure whether you need a regulatory affairs expert on your team, here are some signs that it might be time to make the investment:

  1. You’re not familiar with the regulatory landscape for the regions you intend to market your device.

  2. You’re not sure what clearance or approval pathway is required for your device.

  3. You need help developing a regulatory strategy to make sure your device complies with all relevant regulations.

  4. You need someone to manage submissions and interactions with Regulatory Authorities.

  5. You’ve received a warning letter from FDA or another regulator.


Benefits of Hiring a Regulatory Affairs Expert

When your medical device startup is ready to bring a new product to market, you need to ensure that it meets all the necessary regulatory requirements. This can be a daunting task, especially if you're not familiar with the regulatory process.


A regulatory affairs expert can help you navigate the complex world of medical device regulations, ensuring that your product meets all the necessary requirements for approval. For example, they can review your device description and claims you intend to make to determine if your product is indeed a device. From a US perspective, they will tell you all the applicable FDA regulations, consensus standards, and guidance documents. A Regulatory Affairs Expert can provide you with a detailed list of the verification and validation testing that will be required for regulatory submissions. They can also help you develop a comprehensive strategy for compliance throughout the entire product lifecycle.


There are many benefits to hiring a regulatory affairs expert for your medical device startup. Here are just a few:

  1. Save time and money: A regulatory affairs expert can save you time and money by helping you avoid costly mistakes in the regulatory process. They can help make sure test protocols will meet all FDA requirements prior to execution. They can provide you with FDA review fees and estimates for the cost of required performance testing.

  2. Gain peace of mind: With a regulatory affairs expert on your team, you'll have peace of mind knowing that your product is compliant with all applicable regulations. With their experience, they know what issues may come up and help you navigate those.

  3. Lead the regulatory strategy: A regulatory affairs expert can help you understand exactly what premarket submissions are required (510(k), De Novo or PMA) and help your company plan the performance testing to be completed.

  4. Quality management system support: A regulatory affairs expert can help you implement and make strategic decisions on your quality management system implementation. Thinking of using an electronic quality management system? Chances are they have experience with these and can help guide you towards the best solution and support efficient implementation.

  5. Focus on what you do best: Hiring a regulatory affairs expert frees up your time so that you can focus on what you do best - developing innovative new products.


When to Hire a Regulatory Affairs Expert for Your Medical Device Startup

If you're working on a new medical device, you'll need to navigate the complex regulatory landscape. The FDA has strict rules and regulations for medical devices, and it can be difficult to keep up with all the latest changes released in new FDA Guidance Documents.


A regulatory affairs expert can help you understand the FDA's requirements and make sure your device is compliant with any premarket clearance or approval requirements and quality management system requirements. They can also help you prepare for FDA inspections and audits. If you're not sure whether you need a regulatory affairs expert, here are some signs that it might be time to hire one:

  • You're not familiar with the FDA's regulations

  • You would like to initiate a conversation with FDA to understand their perspective on your device

  • Your device prototype design is complete. You are ready to launch and need a global regulatory strategy.

  • You're not sure how to prepare for an FDA inspection

  • You want someone to review your product before you submit it to the FDA

  • You need help creating labeling and marketing materials

  • You want someone to handle communications with the FDA

If any of these apply to you, it's time to start looking for a regulatory affairs expert. The sooner you bring one on board, the better positioned you'll be to get your device approved by the FDA.


Important Qualities to Look For in a Regulatory Affairs Expert

There are a number of important qualities to look for when hiring a regulatory affairs expert for your medical device startup. Here are some of the most important:

  1. Extensive experience in the medical device industry: A regulatory affairs expert should have extensive knowledge of the medical device industry, including experience with 21 CFR 820 and ISO 13485. They should have a track record of successful 510(k)s, De Novos or PMAs with the FDA.

  2. Strong communication and writing skills: A regulatory affairs expert should be able to effectively communicate with you and other members of your team, as well as with health authority personnel. They should also have strong writing skills in order to prepare comprehensive reports and submissions.

  3. Ability to think strategically: A regulatory affairs expert should be able to think strategically about your product and its place in the marketplace. They should be able to identify potential problems and opportunities and develop strategies to address them.

  4. Attention to detail: A regulatory affairs expert must pay close attention to detail to ensure that all required information is accurately filed and submitted on time. They should be able to review verification, validation and clinical reports and easily identify any items that may be a red flag for the FDA.

  5. Flexibility and adaptability: The regulatory landscape can change rapidly, so a regulatory affairs expert must be flexible and adaptable to keep up with changes and ensure that your product remains compliant.

Conclusion

Hiring a regulatory affairs expert can be critical for any medical device startup’s success. Regulatory guidance and compliance are essential to ensure the safety and effectiveness of your product before it reaches the market. When evaluating when to bring on an expert, consider the complexity of your product, its timeline for development, as well as the resources that you need to stay compliant with industry regulations. Make sure that you do your due diligence and research ahead of time so that you can find the best fit for your team and help push your medical device startup forward.


Schedule a free, 30-minute initial consultation with our experts at Folio Consulting Group, LLC to see how we can provide your team with regulatory assistance and help prepare your regulatory strategy.



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