Outsource Medical Device Regulatory Services

Medical Device Regulatory Services

Choose our medical device regulatory support and efficiently streamline your medical device production and development processes. Prices start at $1280 per FTE per month

Is your company on the lookout for methods to efficiently streamline the medical device development process? Are you currently struggling to find reliable resources that can help you with proper healthcare device regulatory solutions? If you are finding yourself overwhelmed with the increasing demands and requirements of the healthcare industry for efficient medical device development, it is better to outsource reliable healthcare device regulatory services to a professional company.

Flatworld Solutions is a provider of healthcare device regulatory services that use advanced technology and tools to deliver the best results to clients. With the industry experience of more than 20 years, our knowledgeable and skilled team can take care of every single aspect of proper healthcare device regulatory processes. From design to implementation and from monitoring to skill assessment, we can do everything.

Medical Device Regulatory Services We Offer

Our services include -

  1. Comparative Analyses

    Comparative Analyses

    FWS utilizes the best methodologies and technologies to efficiently streamline the non-clinical testing processes and support all medical devices. With our physiological and biomedical experts, such methodologies can successfully be implemented into the healthcare device regulatory processes.

  2. Design Assessment

    Design Assessment

    With more than 20 years of experience in handling different medical devices and products, Flatworld Solutions can offer the best design expertise and guidance for succeeding in the healthcare device regulatory field.

  3. Risk Analysis & Mitigation

    Risk Analysis & Mitigation

    Our expert professionals will help you perform the most effective and efficient risk assessment processes for the proper regulation and development of medical devices. Not just that but we are also offering mitigation strategies to ensure proper regulation in the process. Opting for our healthcare device regulatory services will enable you to experience the best benefits.

  4. Pre-clinical Evaluations

    Pre-clinical Evaluations

    We have a proper healthcare device regulatory consulting team that can offer pre-clinical and regulatory testing strategies that can help in outlining all the necessary testing that is required for supporting the goals of your medical device company or healthcare centre.

  5. Clinical Evaluation Reports

    Clinical Evaluation Reports

    Our professionals at FWS are completely adept in the Medical Device Regulations and can provide complete CERs as well as literature reports for healthcare centres all over the world. Opting for our healthcare device regulatory solutions can get your company proper evaluation reports from experts.

  6. FDA Submissions & Reports

    FDA Submissions & Reports

    With our healthcare device regulatory team by your side, your company will be offered the best-quality FDA submissions for sure. FWS has experience with most complex submissions and we can guarantee that you will receive proper support throughout the entire healthcare device regulatory submission procedure.

Other Services You Can Benefit From

Why Choose Us as Your Medical Device Regulatory Services Company?

Being able to outsource medical device regulatory services to Flatworld Solutions can be beneficial to your company. Some reasons to choose us include -

  • Affordable Rates

    Business owners and healthcare centres that come to us want stellar services and that too at an affordable rate. So, we make it our mission to provide the best rates to our clients.

  • Information Security

    We are an ISO-certified firm that specializes in medical device regulatory and compliance solution providing. Hence, all your information and company data will be kept safe and secure.

Client Success Story

FWS Provided Patient Onboarding Services to a US-based Pill Provider

FWS Provided Robust and Reliable Patient Onboarding Solutions to a US-based Healthcare Provider

A leading US-based healthcare firm was looking for reliable patient onboarding services. Our team of professionals provided the client with exceptional services and value for money.

Read the case study
FWS Provided Accurate and Timely Teleradiology Solutions to an American Medical Imaging Provider

FWS Provided Accurate and Timely Teleradiology Solutions to an American Medical Imaging Provider

A leading American medical imaging provider required professional help to reduce its teleradiology backlog. Our team of remote and professional teleradiologists provided the required high-quality services quickly and effectively reduced the backlog to zero.

Read the case study


I am highly impressed by your hard work and superb quality of service! You also charge very reasonable prices. Thank you a million times!!

Assist. VP, Medical Company, VA More Testimonials »

Outsource Professional Medical Device Regulatory Consulting Services to FWS Today

With our talented device regulatory team, you can ensure that the best procedures and tools are being used in your healthcare organization to provide stellar results in the end. If you are searching for a reliable regulatory services company, there is no better choice than Flatworld Solutions.

Contact us to learn more.

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Flatworld Solutions

116 Village Blvd, Suite 200, Princeton, NJ 08540


Aeon Towers, J.P. Laurel Avenue, Bajada, Davao 8000

KSS Building, Buhangin Road Cor Olive Street, Davao City 8000

Our Customers

  • Movement Mortgage
  • Alcon
  • ARI
  • Maximus
  • Redwood E-Learning Systems

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