Happy Scientifics Limited ®

Navigating Clinical, Regulatory and Quality Challenges Together

Welcome to Happy Scientifics Ltd., a clinical, regulatory and quality consulting firm dedicated to guiding medical device and in vitro diagnostic medical device companies through the ever-changing and complex global regulatory environment. We understand that navigating the regulations for medical devices can be challenging, especially for small and medium-sized companies. That’s why we offer a flexible consultancy support service that is tailored to meet the unique needs of each client and market.

Thanks for visiting “Happy Scientifics Ltd”. I am Dr. Siddiqul Haque, founder and Director at Happy Scientifics Limited, a medical device consulting firm based in Gravesend, UK. Educated as MD, Master and PhD in Biomedical Engineering/theoretical medicine along with over 18 years of professional experiences as a medical doctor, as well in the medical device, in vitro diagnostics (IVD) and pharmaceutical industry, I am a strong clinical and biomedical engineering professional. I am a registered physician in Germany and have excellent communication skills.

My expertise includes regulatory and clinical affairs consulting, medical writing, EU-MDR/IVDR gap assessments, technical file remediation, Clinical Evaluation Report (CER), PSUR, PMCF, Scientific Validity Report (SVR), Performance evaluation report (PER), Analytical performance report (APR), Clinical performance report (CPR), Biocompatibility assessments, Clinical Investigation, Pharmacovigilance, Risk Management, Periodic Safety Update reports, and performing gap analysis for MDD to MDR transition, IVDD to IVDR transition, ISO 13485, ISO 9001, ISO 14155/ICH GCP, ISO 17021, ISO 11607, Sterilization, Quality Management System and CAPA management.