Over 10 years we help companies reach their financial and branding goals. Engitech is a values-driven technology agency dedicated.

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411 University St, Seattle, USA

engitech@oceanthemes.net

+1 -800-456-478-23

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Expert Guidance in
Medical Device Innovation

MedStrategist provides expert consultancy in Medical Device Regulatory and Quality Management, specializing in implementing systems for compliance, sustainability, and growth through strategic, cutting-edge frameworks, with a focus on knowledge transfer through training.

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About MedStrategist

Comprehensive Expertise
in the Medical Device Industry

At MedStrategist, led by S L Sriram, we excel in managing complex projects within the medical device sector. With a proven track record, we specialise in implementing practical, effective strategies at the operational level, which has contributed to our long-standing success in the field.

Our Services

S L Sriram MedStrategist Services

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Quality Management System (QMS) Implementation
  • ISO 13485 implementation for Medical Device Quality Management Systems
  • Comprehensive compliance support for the Indian Medical Device Regulation (I-MDR 2017), European Medical Device Regulation (EU MDR 2017/745), and US FDA 21 CFR 820 QSR
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Regulatory Submission Support
  • Indian CDSCO: Registration, Test Licenses, and Manufacturing Licenses
  • EU MDR: Technical File Compilation and MDD Extension
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Training Programs
  • ISO 13485 implementation for Medical Device Quality Management Systems
  • Comprehensive compliance support for the Indian Medical Device Regulation (I-MDR 2017), European Medical Device Regulation (EU MDR 2017/745), and US FDA 21 CFR 820 QSR
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Product Development & Innovation Support
  • Indian CDSCO: Registration, Test Licenses, and Manufacturing Licenses
  • EU MDR: Technical File Compilation and MDD Extension