About

Happy Scientifics Limited ®

Face the regulatory challenge

Recognizing the challenges that manufacturers face in bringing medical devices to market in the constantly evolving regulatory environment, especially after the EU MDR was published, manufacturers were struggling to cope with stringent requirements posed by newer regulations. I, Dr. Siddiqul Haque have been working with EU MDR since it was published and found manufacturers have difficulty in understanding and implementation of the stringent newer regulations. I founded Happy Scientifics in 2019 to provide specialized Clinical, regulatory and quality consulting services. Through my experience, I saw a clear need for support in understanding and implementing regulatory requirements, particularly for small start-up organizations who may feel overwhelmed by the regulatory landscape.

Our Commitment to you

We are committed to positioning our clients for success through our
top-notch experience and knowledge, as well as our enterprising
culture that allows us to provide guidance in accordance with the
latest standards and regulations. Our mission is to lead your
organization forward by building a strong partnership based on trust,
integrity, and unmatched client focus.
We are dedicated to providing experience, knowledge, and guidance
to meet your global quality and regulatory requirements, while
incorporating exceptional service, value, and a balanced business
approach. Through an extraordinary work ethic and industry best
practices, we will consistently exceed your expectations as we work
towards your established goals.

We are committed to maintaining the highest standards of integrity and honesty in all of our business practices and are dedicated to building long-term, trustworthy relationships with our clients. We are dedicated to providing the support and guidance our clients need to succeed in the highly regulated medical device industry.

Take our support for a smooth entry into the market and easy existence

At Happy Scientifics, we support a wide range of medical device companies by providing regulatory, quality, and clinical support. From small start-ups to larger established manufacturers, we have the expertise to guide our clients through the regulatory process. Additionally, my experience as a Class III expert reviewer for a Notified Body gives me valuable insight into the expectations of regulators. At Happy Scientifics, we provide clinical, regulatory and quality consulting services for medical device companies. Our team of experts has extensive experience in navigating the complex regulations and guidelines set forth by the FDA, EU, UK MHRA and other international regulatory bodies.

In EU, US, UK and beyond

We offer a range of services for the EU and US medical device market, including complete preparation of Clinical Evaluation Report (CER) including literature search according to MDR, Post Market Clinical Follow-up (PMCF), assistance with pre-market submissions, such as 510(k) clearance and PMA approval, IVDR transition, MDR transition as well as post-market surveillance and reporting. We also provide Quality Management system development and audits, risk management, and compliance support. Our goal is to help our clients bring their innovative medical devices to market quickly and efficiently, while ensuring compliance with all relevant regulations. We work closely with our clients to understand their unique needs and develop customized solutions to support their success. With Happy Scientifics as your regulatory and quality consulting partner, you can be confident that your medical device is on the path to regulatory approval and commercial success