About

Happy Scientifics Limited ®

Face the regulatory challenge

Recognizing the challenges that manufacturers face in bringing to place medical devices in the 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 that the manufacturers have difficulty in understanding and implementation of the stringent newer regulations. Happy Scientifics Ltd was founded Happy Scientifics in 2019 to provide specialized Clinical, regulatory and quality consulting services. Through our experiences, We 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 position our clients for the success through our top-notch experience and knowledge, as well as our enterprising culture that allow 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 provide 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 maintain 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 provide the exact 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 Ltd, we support a wide range of medical device companies/manufacturers 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, our experience as Class III expert reviewer for a Notified Body gives us valuable insight into the expectations of regulators. At Happy Scientifics Ltd, we provide clinical, regulatory and quality consulting services for medical device companies/manufacturers. Our team of experts has extensive experience in navigating the complex regulations and guidelines set forth by the, EU, UK MHRA, FDA, Canada, Latin America including Brazil, Japan, Australia (MDSAP Medical Device Single Audit Program), Middle East including Dubai, KSA (Kingdom of Saudi Arabia Saudi FDA), and other international regulatory bodies from rest of the world.

In EU, US, UK and beyond

We offer a range of services for the UK, EU and US medical device market, including complete preparation of technical documents including Clinical Evaluation Report (CER) including literature search according to MDR, Post Market Clinical Follow-up (PMCF), supporting with Person Responsible for Regulatory Compliance (PRRC) in the EU, Authorised Representative service in the UK & EU as well as auditing, assistance with pre-market submissions, such as 510(k) clearance and PMA approval, IVD to IVDR transition, MDD to 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 Ltd. 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

AREAS OF EXPERTISE :

  • Medical Writing: Clinical Evaluation Report Writing including literature
    Search, review & assessment, Post Market Clinical Follow-up (PMCF)
  • Clinical Investigation
  • EU-MDR gap assessments
  • Risk management: ISO 14971
  • UKCA registration including Authorised Representative Service
  • Auditing
    ❖ MDSAP (Medical Device Single Audit Program)
    ❖ Pharmacovigilance: EU Volume 9b, PV/Adverse Events, Directive
    2001/82/EC
    ❖ supplier quality systemUK,
    ❖ GxP audits for the pharmaceutical, medical device and related industries
    ❖ Clinical investigation in Clinical Audit
    ❖ 21 CFR part 210/211, 820, part 58 (GLP), 21 CFR part 600
    ❖ Canada GMP
    ❖ ICH E6 /ICH Q10
    ❖ Sterilization
    ❖ German Pharmaceutical Act (Arzneimittelgesetz – AMG)

Use our service for

  • Registration of your medical device worldwide: EU, US FDA, UK, Saudi FDA,
    Brasil, Canada CMDCAS…..
  • Clinical Evaluation Report writing including literature search and analysis /
    Medical Writing
  • Training your employees
  • Auditing: Internal, external, supplier, MDSAP, clinical investigation
  • MDR/IVDR Transition
  • Quality Management
  • Ready-made Templates and Tools
  • Authorised Representative Service
  • Internal & external audits