Services

Regulatory

In order to get to any market of your choice, there are a lot of regulatory hurdles that you must get through. Once you are into the market, another set of post-market requirements and several other compliance requirements need to be adhered to. Having served the medical device industry for over two decades, we help you navigate through both premarket and postmarket regulatory hurdles as your trusted regulatory partner. We’ve collectively completed over 100 successful submissions and have served as the Regulatory Representatives of companies.

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Quality

Having your customers look up to you for the quality of your product is something which every medical device company wants. We have served as a trusted quality systems advisor and service provider for companies who wanted to establish contract manufacturing set ups, virtual medical device companies, OEM facilities, design houses, and software development firms, where world class quality standards are adhered to. We’ve collectively completed over 1000 audits and have served as the QA Representatives of medical device and IVD companies.

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Clinical

In order to show that your product works in the best interest of the patients and truly adds value, you have to demonstrate that your product is clinically relevant. At times you’d also have to conduct clinical validation. We’ve helped companies address issues such as identification of location of testing, appropriateness and compliance of protocol to GCP requirements, etc. We’ve created over 50 Clinical Evaluation Reports (CERs), where all the clinical and/or published data was presented to establish clinical safety and efficacy.

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Product

The journey of product development and product sustenance is not easy. Companies have to think about what medical device specifications to set, what suppliers to choose and how to qualify them, what testing to conduct, what level of clinical validation is sufficient, what design changes to make, and similar other questions. At every step, it's important to keep the final goal in sight for continued compliance. We’ve helped with both DHF creation for a new product, and remediation and ongoing design control compliance for old products.

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