Our Capabilities

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We formulate tailored regulatory strategy reports that align with your business objectives, guiding your medical device from conception to commercialisation through the complex regulatory landscapes of global markets.

If you need to conduct a clinical study, we can help you prepare a comprehensive and regulatory-compliant technical dossier tailored to your requirements. We will work closely with your CRO to ensure your application is thorough, well-structured, and submission ready.

Our QMS development and implementation services focus on embedding quality into your organisation's DNA, building systems that promote continuous improvement, ensure compliance, and drive sustainable success in the medical device industry.

Our expertise in technical file development ensures your product documentation is comprehensive, clear, and compliant, effectively demonstrating the safety and performance of your medical device to regulatory authorities.

With our 510(k) development services, we not only assist you in creating a comprehensive 510(k) submission for U.S. FDA, but we also guide you through the entire submission process. Our support ensures a seamless journey through regulatory scrutiny, enhancing your chances of a successful review and expeditious market entry in the United States.

Through thorough clinical evaluation plan and report development, we help you consolidate scientific evidence to demonstrate the clinical safety and performance of your device, a critical component in gaining market approval.

Devices that come into direct or indirect contact with patients or users require a comprehensive biological evaluation. In collaboration with our trusted partner labs, we offer comprehensive biological evaluation and testing services to ensure your device meets biocompatibility requirements.

Regulators worldwide are placing greater emphasis on human factors and usability engineering for medical devices. At MedCompliance, we will work closely with your technical team to mitigate use-related risks as far as possible and prepare robust documentation for regulatory submissions—ensuring your application stands the best chance of success.

Our post-market compliance services ensure your medical device continues to meet evolving regulations and standards, safeguarding its market presence and upholding the trust of users and regulatory bodies alike.