Krupa Srivastava, M.Sc BME

An established professional in Regulatory Affairs and Quality Assurance, Krupa brings over 12 years of experience working with innovative Start-ups as well as global Medical Device and Pharmaceutical Organisations both in the UK and USA. She loves engaging in different technologies and brings a wealth of expertise working with devices in the field of electro-medical equipment's such as portable ventilators, Laparoscopic equipment's, non-electrical body implants, borderline products such as oral solutions in Gastroenterology etc. Please checkout the LinkedIn profile for a list of clients.

Krupa has a bachelors degree in Electrical Engineering and earned her Masters Degree in Biomedical Engineering from Drexel University, Philadelphia, USA.

Areas of Specialty

At The RegAffairs Ltd, we can provide you the following services. If there is something else you require, please do not hesitate to contact us.

Regulatory Affairs

Compliance to MDD/ MDR
UK Responsible Person
Subject Matter Expert and Liaison for Notified Body Audits
510(k) Submissions
Official Correspondent for FDA Furls and Device Listings
MDSAP
Technical Documentation/Dossiers
International Registrations (UK & EU, TGA-Australia, Health Canada, US FDA, Medsafe-NZ, MHLW- Japan and more)
Independent Reviewer/ Design Reviews
Vigilance Reporting
Post Market Surveillance
Regulatory Strategy for new as well as existing Product launches

Quality Assurance

ISO 13485 Gap Analysis
Internal Audits
QMS Documentation- Manual, SOPs etc.
QMS Processes Implementation
Risk Management to ISO 14971
Training on Regulatory Compliance, QMS requirements/standards, regulations or international registrations.

The RegAffairs Ltd

Regulatory affairs and quality assurance for medical devices

Krupa Srivastava, M.Sc BME

Areas of Specialty

Regulatory Affairs

Quality Assurance

This website uses cookies.