Happy Scientifics Limited ®
The one step solution for Clinical, Regulatory and Quality Challenges for medical device manufacturers.
Welcome to Happy Scientifics Ltd., a clinical, regulatory and quality consulting firm dedicated to guide 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
hallenging, 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.

Dr. Siddiqul Haque
MD, MSc (Biomedical Engineering),
PhD (Theoretical Medicine/Biomedical Engineering)
Thanks for visiting “Happy Scientifics Ltd”. I am Dr. Siddiqul Haque, founder and Director at Happy Scientifics Limited, An international medical device consulting firm based in Gravesend, UK. Educated as MD, Master and PhD in Biomedical Engineering/theoretical medicine along with over 25 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.

Services offered by Happy Scientifics Ltd.

Clinical/Medical Writing
Your partner in medical writing

Regulatory Affairs
Your partner in regulatory strategy and submission

Auditing
For all internal & external audits

Training
tailored to your organisation

MDR/IVDR Transition
IVDR/MDR Gap Assessment & Remediation

Templates and Tools
fixed-fee packages tools and templates

Quality Management
QMS implementation and Product Quality Compliance

EU/UK Authorised Representatives & PRRC
As your EU Authorised Representatives