Welcome to Eunoia Compliance
Consultancy for Biological Safety of Medical device
Strategic planning,
Organizing Biological and chemical testing,
Toxicological risk assessment
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Toxicological risk assessment
The first step in biological evaluation is the gathering of physical and chemical information on the medical device, materials or component.
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Gap Assessment
Our experts can help you in performing a Gap assessment and planning further regulatory strategies based on the Gap assessment.
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Failed biocompatibility test
We help you to understand the reason for failure, evaluate and create a technical memorandum for an adverse test result
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Particulate testing of medical devices
Particle testing of medical device can be challenging. Our team have the expertise to provide you support from developing simulated use model to writing protocols and reports.
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Technological advances in the last three decades have provided exponential growth to the medical device industries. Bringing any medical device to the market requires regulatory approvals. With an ever-changing technology – regulations and standards are also constantly evolving. These regulations are made keeping safety of the patient at its core and that is also our goal.
At Eunoia Compliance, we understand the need of our clients. Be it an existing product that needs compliance with new regulation or a new product, we understand that you want accelerated, timely and continuous approval of your products. We believe that every client and every project is unique. Whether, biocompatibility of your product, particle testing or risk management, we provide personalized consultancy services which is tailored to your requirements.