Mohan Raghul Baskaran

Expert Medical Device Quality and Regulatory Affairs - MDQMS ISO 13485:2016, US FDA 21 CFR Part 820 QSR, Risk Management (ISO 14971:2019), Regulatory Compliance-EUMDR, IMDR, Medical Devices - PMS, DHF and V&V

Role: Scientist C (Quality and Regulatory Affairs) at Andhra Pradesh Medtech Zone Limited
Location: Chennai, TN, IN
LinkedIn followers: 500 followers

ScienceView LinkedIn profile

About Mohan Raghul Baskaran

As a Quality and Regulatory Affairs Scientist at Andhra Pradesh MedTech Zone Limited, I…

Experience

Scientist C (Quality and Regulatory Affairs)
Andhra Pradesh Medtech Zone Limited
May 2022 — Present · Visakhapatnam, IN
Medical Device Regulatory Affairs, Quality system Regulation, Risk Management, Risk compliance, ISO 13485:2016, CAPA- Corrective Action Preventive Action, New Product development, FMEA- Failure Mode Effective Analysis (Design, Product, Process and Software), SDLC,FTA, ISO 14971, ISO 62304, ISO 42001, IMDR, USFDA, CE, 21 CFR 820, NPD, Regulatory submission, Post market Surveillance, complaints handling, Medical Device Regulatory and Quality Management Systems.

Contact information

Verified work emails, personal emails, and direct dials — unlocked in one click.

Work email
•••••@amtz.in
Personal email
•••••@•••••.com
Direct dial
+•• ••• ••• ••••

Unlock verified contacts

Free to start · No credit card required

Current company

Andhra Pradesh Medtech Zone Limited

Medical Equipment Manufacturing · 208 employees · Founded 2016 · Visakhapatnam, Andhra Pradesh, India

Medical device manufacturing sector has remained nascent, leading to tremendous import dependency. Lack of domestic manufacturing of medical devices is the main reasons for this import dependency and high cost of medical products and services in the country. To address this situation, Govt. of Andhra Pradesh aims to establish country’s first Andhra Pradesh Medical Technology Zone (AMTZ) at Vishakhapatnam. The goal of this progressive initiative would be to make Andhra Pradesh an internationally recognized manufacturing hub for medical devices, help in national agenda of import substitution, make Andhra Pradesh a leader in medical technology exports, generate employment, and contribute to volume generated cost reduction of medical devices for patients. In a meeting organized on 6th Nov, 2015, The creation of such a zone is based on the fact that medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufactures to invest upon. The zone with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40%-50%. Currently, due to lack of such centrally located sharable facilities, either manufacturers do not undertake production of technologies requiring them or send their products abroad for process up-gradation and value addition. Government of Andhra Pradesh has developed 270 acres of land for this project. The zone have included following facilities over an area of 270 acre: A. Component Testing centre. B. Electro-magnetic interference laboratory. C. Medical grade low vacuum molding, cabinet molding, injection molding centres. D. 3 D designing and printing for medical grade products. E. Sterilization & Toxicity testing centre. F. Radiation testing centre. G. Warehousing. H. Regulator’s office. I. Other facilities commonly required in manufacturing of medical devices. J. Incubation Currently it houses 120+ manufacturing partners

amtz.in

Find verified contacts for anyone on LinkedIn

Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.

Start for free See how it works

Free plan included · No credit card required

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

About Mohan Raghul Baskaran

Experience

Scientist C (Quality and Regulatory Affairs)

Find verified contacts for anyone on LinkedIn