New Product Approval for Medical Devices

According to a 2017 medical device industry survey, “Regulatory changes continue to represent the biggest business challenge to most survey respondents.” With the explosion of innovations in the medical devices industry has come more stringent FDA regulations for companies to follow. It can quickly become overwhelming for businesses of any size to keep up with demands as they seek the approval of a new product, but you don’t have to navigate these new product approval challenges alone.


Let Regulatory Compliance Associates® Inc.’s team of experts guide you through the constantly changing domestic and international regulations to successfully register your medical devices.  From pre-submission strategies to international submission support, our expert team has the unique insight necessary to help you take your products to the next stage of product development.


We offer many new product approval support services that will help you stay within regulatory compliance throughout each stage of the regulatory submission process, including:


Global Regulatory Strategies

Our Statement of Work for 510(k) Submission Services is based on a reasonable, predetermined fixed fee!

When you’re seeking new product approval internationally, you need the guidance of experts that have worked with regulatory authorities around the world. RCA will work with you to create successful global regulation strategies through services such as:


Pre-Submission Support

Before you even submit your product for approval to the top regulatory authorities, you’ll need to have a strategy in place to determine the most appropriate pathway to obtain clearance. You’ll be far more prepared to talk to the FDA and other regulatory bodies as we support you with services including:


  • Preparing and Conducting Pre-Submission Meeting with FDA
  • Regulatory Strategy
  • Evaluation of ISO 13485 and FDA Compliance

Domestic and International Submissions Services

Whether you’re only submitting your product for approval in your own country or are looking to sell in markets around the world, RCA will create a strategy unique to your goals. We help you navigate the 510(k) approval process for medical devices and guide you as you work with regulatory authorities from around the world.


Our domestic and international services include:


  • Technical Writing: 510(k) submissions, PMA submissions, De Novo, Technical Files, Clinical Reviews, Explanation Letters, etc.
  • Submission Preparation and Filing with Regulatory Authorities
  • Facilitation and interaction with regulatory authorities

Post-Submission Services

Submitting your product for clearance isn’t the last step in the product approval process — you’ll also have to register and list your device, and you’ll need to identify a U.S. Agent if you’re a foreign company importing your product into the U.S.


RCA is here to guide you after your device is submitted and can even act as your U.S. Agent to assist in future FDA communications. Our services include:



Contact RCA for Medical Device Regulatory Consulting Services

When you’re looking for a medical device consulting firm for your regulatory pathway, you need a partner with extensive industry knowledge that will customize a solution to meet your needs as you seek the approval of your new product. With a unique blend of industry experts and FDA veterans, the team at Regulatory Compliance Associates® Inc. is here to help.


Since 2000, we’ve worked with thousands of medical device companies like yours around the world to resolve regulatory challenges throughout the product submission process and smooth the path to approval. Whether you’re a small startup or multinational corporation, we take your needs into account as our team of industry specialists tailors the ideal strategy for you.


For more information or to request an FDA consultant service for your medical device, use the form below to contact us today.

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