Medical Device Regulatory Services

Helping you navigate the often complicated path to compliance, our medical device regulatory experts provide you the guidance you need to market medical devices in countries around the world. We leverage our certification and technical expertise to give you confidence in both your products and the compliance process.

Medical device regulation is dictated by country, as well as by product type. The requirements for electrical products, for example, can be vastly different from implantable devices or home health products. We provide a full suite of services to ensure that you remain in compliance, no matter where you plan to market.

Our Medical Device Regulatory Services

We understand that producing a great product is only one part of the development process. We use our experience in medical device regulatory affairs to ensure that all of the requisite documentation, certifications and compliance requirements for your product are complete, and help you complete any registrations or legal filings required for your medical devices.

Our certification and regulatory experts understand the challenge of developing medical products for global export and assist you in achieving increased speed to market, resulting in successful product launches.

We assist with multiple aspects of your project, including:

Documentation and procedure review
Product registration support
Design guidance and gap analysis

For those that need guidance on the regulatory requirements for a particular product, we can provideEarly Stage Qualification (ESQ®)services to support them through the testing and approval of their products and components.

Medical Device Regulatory Affairs

Additional Medical Device Services

In addition to medical device regulatory guidance, we provide testing and certification services for a wide variety of medical devices and products.

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Some of our testing services include:

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Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.

making certain for nearly 190 years

Medical Device Radio Testing

我们的医疗监管事务专家可以identify the appropriate Radio Testing standards and certification, helping to remove both the cost and risk from medical product verification and validation during the formal testing phase.

Additional Medical Device Testing 640 x 480

Medical Device Wear Testing

Typical devices that Element performs wear testing on include Hip Prostheses, Total Knee Replacements, Spinal Device, and Small Bone or Join Replacements.