Organisation Profile

1. MeDStrategist
Medical Device Strategist
Strategy developer, Design Consultant
and Implementer for Medical Device
Industry

2. Decades of sales and Service experience in varied organisations from small to multi-billion dollar Multinationals with
proven track record in meeting customer requirements
Marketing communications, Product marketing and creating marketing strategy with proven track record of taking
every product position to no 1 or no 2 positions in its market
Project management of complex projects, implementation of strategies at ground level have been the hall mark of a
long career
Product Development as Head of Design and Development – created 8 Medical Devices in Diagnostic, Therapeutic,
Imaging, Unique first of its kind IoT device – that won 7 international awards for Innovation in Design and Technology
Establishing manufacturing set up from concept to product roll-out, technology selection & transfer, sourcing &
product realization and manufacturing operations. 4 Technology transfers and 3 manufacturing units
Expertise and Experience in Regulatory & QMS with thorough knowledge on ISO 13485, ISO 9001, ISO 14971, IEC
60601, MDD, IVD, FMEA, GMP-Medical Devices, CAPA
Training expertise on Products, Applications, Technology, Processes, Regulatory, Soft skills across the levels of the
organisation
About MeDStrategist
MeDStrategist started by S L Sriram having over 39 years experience in Medical Device industry
His full profile can be accessed at https://www.linkedin.com/in/sriramsl/

3. Strategic
Areas of
operation
QMS & REGULATORY
Implementation of ISO
13485 and Regulatory
approvals for CE, IMDR
MED-DEVICE DESIGN
TRAINING
MANUFACTURING SET UP
TECH TRANSFER
PRODUCT LOCALISATION
MARKETING
MeDStrategist
Design consultancy from
Concept to Product roll out
of Medical Devices – in X
Ray, Critical Care, IoT
products
ISO 13485 Awareness
and detailed training,
Internal Auditors Training
FMEA, Risk Management
Training,
Setting up Green field
manufacturing unit for
Medical devices from
concept to production
Technology Transfer or
Acquisition through
Technology Quality Due
diligence, negotiation,
valuation and transfer
agreement,
Creation of Market and
Product Strategy
through market analysis
for Medical Devices
Make-in-India
localisation of Medical
Devices through Re-
engineering and efficient
sourcing

4. Companies Worked For Companies Worked With

5. Designed Products Portfolio – Few Examples
Mobile C Arm
ECG Machines
Mobile X Ray Defibrillators
Patient Monitors
IoT Devices
Wireless Stress
Test Systems

6. Product Portfolio – Few Examples – Under Consultancy

7. Green Field Manufacturing Set up
Started the Shimadzu India Pvt Ltd
and established a manufacturing
unit, through indigenising the
product by qualifying the local
sources. Green field project from
decision to first product roll out in
11 months
HF X Ray System
From proposing to convincing to
negotiating to creating a JV for
manufacture of Ultrasound systems
in India with Aloka, Japan
Establishing manufacturing unit as a
green field project and execution for
product roll out through efficient
Sourcing
Key Challenge – Sourcing of Components that meet Japanese Quality Requirements in India

8. Medical Device Regulatory
Regulations
• European MDD,
IVD and MDR
• Indian MDR
• ANVISA
Processes
• QMS ISO 13485-
2016
• RMF ISO 14971
• SDLC IEC 62304
• Usability IEC
62366
• Performance
and Safety IEC
60601-1 #
Products *
• Defibrillator
• ECG Machine
• Patient Monitor
• X Ray Machine
• Mobile C Arm
• Anaesthesia
Module
• IoT Device
• Public Access
Defibrillator
• Stress Test
System
• Fluorescence
Imaging System
• IVF- ART Device
• Ureteral Stents
Trainer
• ISO 13485-2016
• RMF ISO 14971
• SDLC IEC 62304
• Usability IEC
62366
• Performance
and Safety IEC
60601-1
• Internal Auditor
ISO 19011
• Medical Device
Regulation (EU-
MDR)
* Obtained CE Marking for these products
# Excluding EMI/ EMC 60601-1-2
Certified Medical Device Professional and Technical File Reviewer for MD 1100, MD
1101, MD 1201, MD 1301, MD 1302 and MD 1402)
Advisor and Consultant
on
Design, MFG Process,
QMS Implementation
and TF Preparation for
- Irillic Pvt Ltd
- Blueneem Medical
Devices
- Spovum Technologies
- Kornerstone Devices
Empanelled Trainer for
- SGS
- DQS

9. CONTACT
Medstrategist (OPC) Pvt Ltd
A008, Value Plus
Narayana Nagar
Anjanapura Main Road
Doddakallasandra
Bangalore – 560 062
India
+91 9739895559
Sriram@medstrategist.com
MeDStrategist