Let Regulatory Services Company help your company be compliant with FDA and ISO!
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Expert Regulatory Consulting Services for Your Medical Device Business
Navigating compliance and regulations with confidence.
About Regulatory Services Company
Our Mission
At Regulatory Services Company, our mission is to provide exceptional consulting services tailored to meet the unique needs of our clients. We strive to help businesses navigate the complexities of regulatory compliance and achieve sustainable growth.
Our History
Regulatory Services Company was founded in 1994. Since then, we have been able to help hundreds of new or improved products be introduced into the US and worldwide markets.
These products have included life-saving, life-sustaining products that have been instrumental in preserving life in tens of thousands of people all over the world. In fact, the odds are that one or more of the products we have helped get into the hands of talented medical professionals has saved or improved your life, or that of one of your loved ones.
We wish we could disclose all the companies we have worked with over the past 30 years and all of their products, but we can't do that. Just like we won't later disclose our work with your company to someone else.
For devices intended for commercialization in the U.S.
US Medical Device Regulatory
Premarket Activity Planning and Monitoring
FDA Submissions Required
Presubmission Meetings with FDA
Post-Approval Surveillance
Post-Approval Submissions
Our Expertise is Safe, Effective Medical Devices
Management Consulting
Unless every employee and agent in a medical device business is wholly engaged in designing, manufacturing, delivering, and servicing a safe, effective medical product, or whichever part of this is your business, your business will not be successful. All it takes to fail is one member of your team - from CEO to loading dock worker - to disregard your corporate passion for safe, effective medical products you would want to be used on a member of your own family. Physicians, nurses, and all other healthcare professionals know a quality product when they use it and you only have one chance to make that first impression.
Let us help you help others. If you need an expert medical devices consultant to come onsite to inform or train your team on the importance of doing things correctly, we are happy to help.
Quality Assurance Planning
The adage in any design and development company is that failure to plan is just planning to fail. Planning to succeed begins with the creation of a Risk-based Quality Management System. This means written Quality Procedures that are easy to read and understand by the employees and agents responsible for following them - a lot of written procedures! If you were to count the number of times the US federal law for medical devices specifies the need to "establish and maintain" a procedure, you would probably stop somewhere over 100.
However, even a group of 100 written procedures is not adequate. Depending on the size and sophistication of your business, plan on 3-4 additional procedures for each of the mandated procedures. More than that, though, if the procedures are so complex or convoluted that only an Appellate Court judge can wade through the myriad of words and phrases, then the procedure is worthless. US FDA and ISO auditors routinely take a copy of the written procedure to the person who is supposed to follow it and ask, "Can you explain this to me?" If your employee can't explain it, a deficiency is noted. You don't want that type of "unforced error" in your company.
We can provide easy-to-implement and easy-to-use written procedures. We'll even come onsite and train if you want.
Risk Management Consulting
Our Risk Management Consulting services will help you make the best decisions about the products you choose to develop and the way you proceed with development. All products must be assessed for the potential risks and possible or likely benefits they offer to medical professionals and their patients.
We can help you create a risk management matrix to assess both risks and benefits. Our founder is a licensed medical professional who can apply his expertise to your products.
Regulatory Submissions
Our services include all manner of submissions to FDA. We are experienced in preparing successful premarket notification submissions (also called 510(k) submissions) for Class II devices and premarket approval applications (PMA) for Class III devices.
If you don't have the staff for preparing and submitting periodic updates, we're happy to help with that, too.
We also have expertise preparing New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics Licensing Applications (BLAs).
We've done it all and we can do it for you, too.
Non-Clinical and Clinical Research
Non-clinical research refers to the bench and animal studies performed to assess a new product. These studies must be designed and conducted to comply with U.S. Federal law or they will not be accepted in the final review process. Typically, these studies seek to determine safety, not effectiveness.
Expect to conduct studies on biocompatibility, including toxicology and perhaps carcinogenicity. All of these studies must be performed on "Final, Finished Goods" not a prototype or early stage mock-up. Make your device, determine if this is what you want to commercialize, then begin the non-clinical studies. Don't expect the FDA reviewers to accept the results of toxicology studies if you change the materials a dozen times before determining the best options for your device.
Clinical studies include all the effectiveness studies of new or altered devices. Always start with small-scale feasibility studies, usually less than 10 volunteer study subjects. Create specific study questions in advance. If the feasibility study answers the questions the way you expect, repeat it on a larger scale, this time with FDA authorization. Since it is a violation of US law to ship an unapproved or unauthorized device across state lines, you need to obtain an exemption referred to as an Investigational Device Exemption, or IDE.
Sound challenging? It is. Sound expensive? Yes, but it's even more expensive if you don't line up all the dots first. Let up help!