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Bijayata has >10 years experience as a medical device regulatory consultant and has specialised in the preparation of technical files for regulatory compliance for UK and EU markets. Her product experience includes: haemodialysis machine, electrosurgical instruments, orthopaedic implants, dental implants, catheters, and various other Class IIa, IIb and self-certified Class I devices according to MDR 2017/745.  She also is has expertise in the preparation of useability engineering files (EN 62366), clinical evaluation reports (MDR Annex XIV and MEDDEV 2.7.1/rev 4), risk management ( EN ISO 14971) and standard compliance reporting (general and product-specific).

Some experience of FDA submission for TENS devices and Class III devices (as per MDR 2017/745) technical documentation preparation.

Bijayata has a degree in Biomedical Engineering and a MSc in Engineering Management.

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