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.
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.

Services

Quality Management System
(QMS) Implementation
Medical Devices QMS Key Elements of ISO 13485 Standard
  • 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
Regulatory Submission
Support
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  • Indian CDSCO: Registration, Test Licenses, and Manufacturing Licenses
  • EU MDR: Technical File Compilation and MDD Extension
Training
Programs
training
  • Quality Management Systems
  • Risk Management for Medical Devices
  • Medical Device Software Development Lifecycle
  • Usability Engineering
  • General Safety and Performance Standards
Product Development &
Innovation Support
product
  • Manufacturing and Technology Transfer

QMS Implementation

Implementing a Quality Management System (QMS) for medical devices demands a focused approach on safety and performance, given the direct impact these devices have on human health. MedStrategist ensures a sustainable, client-empowered QMS implementation, avoiding a mere template-based approach. We tailor the ISO 13485 standard to match the organization’s roles and the type and category of medical devices involved.
With experience across a broad spectrum of product types—Active, Non-Active, IVD, Software as a Medical Device (SaMD)—MedStrategist offers highly specialized implementation for diverse organizations, covering everything from invasive and non-invasive devices to IoT and software.

Regulatory Compliance

Our regulatory compliance strategy follows a step-by-step process, integrating with the QMS at every stage—from concept and design to manufacturing and post-market activities. Our services include:
Indian I-MDR Compliance
Indian I-MDR Compliance

CDSCO submissions for Registration, Test Licenses, Manufacturing Licenses, and post-market approvals

EU MDR Compliance
EU MDR Compliance

Strategic implementation from defining Intended Use to final Technical File submission and deficiency resolution

US FDA Compliance
US FDA Compliance

510(K) pre-market approval support

Product Development & Innovation

Under the leadership of S L Sriram, MedStrategist has contributed to the development of eight medical devices spanning diagnostic, therapeutic, and imaging categories. Notably, Mr. Sriram developed a pioneering IoT device that earned seven international awards for innovation in design and technology.

Manufacturing and Technology Transfer

We provide end-to-end guidance for establishing manufacturing setups, from technology selection and transfer to product realization and operational oversight. Our experience includes four successful technology transfers and the establishment of three manufacturing units.

Regulatory & Quality
Expertise

MedStrategist offers deep expertise in global regulatory approvals and Quality Management Systems. We specialize in ISO 13485, ISO 9001, ISO 14971, IEC 60601, IEC 62304, IEC 62366, EU-MDR, EU-IVDR, and Indian MDR-CDSCO.

Training & Development

We offer comprehensive training programs tailored to various organizational levels, covering products, technology, processes, and regulatory standards. Our training ensures that teams are well-versed in the medical device industry.
MedStrategist

About S L Sriram

S L Sriram, the driving force behind MedStrategist, brings over 43 years of experience in the medical device industry. His extensive career spans roles in sales, service, product development, and project management.

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