I'M
ASHOK SRIRAM
CHANDRA MOHAN
REGULATORY AFFAIRS & QUALITY ASSURANCE (RAQA) CONSULTANT
About Me
I’m an enthusiastic and detail-driven Biomedical Engineer with over 6 years of experience in the medical device industry, specializing in regulatory affairs, quality management systems (QMS), and compliance for diverse technologies including neurostimulators, HIFU systems, ultrasound diathermy equipment, and wearable smart devices.
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My work focuses on regulatory submissions across multiple global markets — including US FDA, EU MDR, and Health Canada — along with drafting and reviewing quality SOPs aligned with ISO 13485:2016. I have extensive experience preparing technical documentation for Software as a Medical Device (SaMD) in accordance with IEC 62304, and hands-on expertise with IEC 60601 and ISO 14971 standards.
Currently, I’m involved in AI/ML-based SaMD projects, supporting regulatory submissions and implementing ISO 13485-compliant QMS to achieve market approvals. I’ve also led the development of De Novo submissions for SaMD and MDR 2017/745 Annex IX technical documentation, collaborating closely with software developers and data scientists to ensure regulatory-ready deliverables.
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I bring strong experience in BSI external audits, software validation for QMS tools, and the ISO 27001:2022 transition, achieving certification with zero non-conformances. Notably, I successfully established a complete QMS under ISO 13485:2016 from the ground up, building a trusted relationship with Notified Body BSI and demonstrating a consistent track record of regulatory excellence.
PROFESSIONAL EXCELLENCE
MY KNOWLEDGE LEVEL IN REGULATORY DOMAIN
PERFORMING DUE-DILIGENCE & REGULATORY STRATEGY
ON MEDICAL DEVICES & SOFTWARE
95%
KNOWLEDGE ON US FDA 510(K), DENOVO, PRE-SUBMISSION
90%
COMPUTERIZED SYSTEMS VALIDATION (CSV)
90%
TECHNICAL PRODUCT DOCUMENTATION PREPARATION
85%
PREPARATION & IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM
90%
DEVICE & PACKAGE LABELING
85%
PREPARATION OF SOFTWARE DOCUMENTS (IEC 62304)
95%
ASSIST ON PROTOCOL PREPARATION FOR BENCH/ANIMAL/CLINICAL TESTING
80%
REVIEW & ASSIST ON ELECTRICAL SAFETY, EMC & PERFORMANCE TEST REPORTS
90%
SUPPLIER AUDIT FOR CRITICAL SUBCONTRACTORS
90%
EXTERNAL AUDIT WITH NOTIFIED BODY (ISO 13485:2016)
90%
EXTERNAL AUDIT FOR SOFTWARE DOCUMENTATION (IEC 62304:2006+AMD1:2015) & CYBERSECURITY DOCUMENTATION (FDA)
EXPERTISE ON ISO 27001:2022 & AUDITING
90%
100%
PORTFOLIO
MY WORKS ON HEALTHCARE INDUSTRY SO FAR
EXPERIENCE
NOV 2018 to MAY 2019
Curneu MedTech Innovations
JUNE 2019 - JULY 2021
Role: Clinical Application Engineer
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Ability to collect data as per protocols and be involved in software, hardware, and clinical testing
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Collected the data for acupuncture treatment and provided inputs to software for the recommendation engine.
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Data mining from e-books and PDF using Python for accumulating data into a dataset
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Curneu MedTech Innovations
Role: Clinical Data Scientist
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Know-how of processing and analyzing clinical data using Python
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Manual testing of software using test cases and hardware using protocols and conducting V&V activities of developing prototype
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Conducted a survey of needles requirements with acupuncturists from various countries of the world and collected the data based on questionnaires and analysis, represented in tools such as Power BI & Tableau
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Identified regulatory requirements for acupuncture devices and needles, the software which developed as per IEC and ISO standards
SEP 2021 to DEC 2022
Elexes Medical Consulting
JAN 2023 - June 2023
Role: Product Specialist - RA/QA
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Involved in the 510(k) submission of various medical devices such as Neurostimulators, Focused Ultrasound systems for Aesthetic use, and Ultrasonic diathermy devices
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Reviewed Electrical safety and EMC report for various medical devices as per IEC 60601-1, 60601-1-2 test standards
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Led the efforts of reviewing Labeling, Biocompatibility test reports, Declaration of Conformity, and drafting various sections for 510(k) submission
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Worked on SaMD products and reviewed software documentation as per IEC 62304 standards
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Involved in solving deficiencies for the submission and submitting FDA AINN/RTA responses
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Worked on HC submission for medical devices and resolved queries on submission
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Elexes Medical Consulting
Role: Product Specialist - I (Due diligence)
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Involved in the performing reviews for product deliverables as per submission requirements for medical devices
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Performing due diligence for various medical devices and SaMD products as per various regulatory requirements and provide inputs to clients
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Reviewing Electrical safety and EMC report for various medical devices as per IEC 60601-1, 60601-1-2 test standards andprovide inputs to TMs
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Assist in reviewing Labeling, Biocompatibility test reports, Declaration of Conformity, and drafting various sections for 510(k) submission as per USFDA requirements
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Performing review of software documentation for various Medical devices and SaMD as per IEC 62304 standards
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Assisting TMs in solving deficiencies for the submission and submitting FDA AINN/RTA responses
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Helping TMs and provide inputs for HC submission for medical devices and resolved queries on submission
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Mar 2024 - Present
May 2023 - Feb 2024
Machine Medicine Technologies
Role: QA & Technical Documentation Officer
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Drafting Product SOPs such as SDLC, Product Identification & Traceability, Change control procedure, Control of Non-Conforming product, Protection Health Information and Sensitive data as the product is a SaMD used for estimating disease severity in Parkinson patients.
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Drafting Software documents such as Software safety classification, SDP, SRS, ADC, SDD, Software V&V, Software Release notes, Maintenance plan, Risk Management file, cybersecurity checklist for security requirements of application as per IEC 62304 and IEC 82304- 1, FDA guidance on content of premarket submission on Device Software functions and IMDRF SaMD - Clinical Evaluation, Risk categorization framework
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Successfully undergoing training on GDPR, HIPAA, ISO 27001 awareness on importance of data protection and security for an organization and achieved 100% success rate on all training.
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Conducting software validation for the tools such as Adobe and executing test scripts for validation of Adobe Acrobat Signature for computerised systems validation and Dropbox for electronic records storage as per 21 CFR Part 11.
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Successfully undergoing external audit with BSI for recertification of ISO 13485:2016 for organization, achieved a 98% success rate and only one non-conformity is observed during evaluation.
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Drafting contents for Pre-submission to the FDA for the submission works of Kelvin-PD and maintaining a good interaction with FDA.
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Sprint discussion & interaction with the FDA on finalizing the works on Intended use & Indications of Use for Labeling of Kelvin-PD
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Drafting all sections of Denovo application for the product Kelvin-PD as per recent FDA's nIVD eSTAR file. • Sprint discussion with the FDA on finalizing the works on Intended use & Indications of Use for Labeling of Kelvin-PD
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Drafting & reviewing the technical documents for another product Kelvin-TD such as clinical evaluation, product description based on the IMDRF and FDA SaMD - Clinical Evaluation.
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Drafting technical documentation for Kelvin-PD as per Annex II - Technical Documentation of MDR (2017/745/EU) and UK MHRA MDR requirements
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Conducting internal and external audit for IEC 62304 standard for technical software documentation of Kelvin-PD.
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Addressing NCRs arised during Internal and external audit for ISO 13485 with CAPA's and achieved 100% effectiveness.
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Investigating various eQMS platforms and analysing its need for an organization for QMS implementation.
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Thymia
Role: Quality & Regulatory Affairs Manager
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Working on ISO 27001 (ISMS) transition from 2017 to 2022 and responsible for updating policies and procedures as per requirements and Statement of Applicability.
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Defining regulatory strategy for Thymia products into various markets such as US, UK, EU and Canada.
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Successfully conducted the transition audit for ISO 27001:2013 to ISO 27001:2022 and recertification for the organisation assessed by British Assessment Bureau with no non-conformities and achieved 100% success rate.
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Preparing Breakthrough devices designation request program for our software to the FDA.
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Working on setting up entire QMS for the organisation as per ISO 13485:2016 and other applicable regulatory requirements.
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Working on Cyber Essentials self-assessment certification for NHS government contracts and successfully achieved the certificate.
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Working on Digital Technology Assessment Criteria (DTAC) to ensure product meets clinical, quality, and safety standards.
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Working on preparing technical documentation for UKCA marking Class I device through self-certification.
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Maintain an effective communication with Notified body for QMS and MDR certification.
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Drafting all relevant procedures (SOPs) for the organisation to implement QMS for the Stage I audit as per ISO 13485:2016.
Role: RAQA Manager
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Analyzing and enhancing existing Quality Management System (QMS) processes to drive continuous improvement and operational efficiency.
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Assessing critical suppliers in compliance with ISO 13485:2016 Clause 7.4 requirements, focusing on medical device manufacturing and authorized representative qualifications.
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Releasing and approving complete systems (devices and treatment kits) for market deployment in accordance with production control and service provision work instructions.
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Collaborating with reviewer on MDR compliance questions (2017/745, UK MDR 2002) to support certification for CE and UKCA marking
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Successfully led the ISO 13485:2016 surveillance audit in compliance with EU MDR and UK MDR requirements, achieving certification with only one minor non-conformance
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Maintaining stock checks and storage unit to maintain and store devices and treatment kits in a controlled environment condition
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Led a team of RAQA Officers to support QMS management, technical file preparation, and global device registration activities.
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Conducted supplier audits to verify compliance with ISO 13485 standards and ensure quality system alignment.
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Served as PRRC and Management Representative, providing strategic plans for continual system improvement and delivering RAQA updates to Top Management during board meetings.
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Implemented updated UK PMS requirements and revised post-market surveillance activities to ensure full regulatory compliance
FREELANCING
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Performing testing on Hoodin (Post-Market Surveillance and Vigilance Tool) to test their functionality, performance with respect to regulatory requirements and provided feedback to the Client
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Conducting Internal Audit on ISO 27001:2002 (ISMS) and ISO 27701:2019 (PIMS) to mdeg (A cloud service provider company) and reviewing the documents to ensure compliance with respect to 2022 standard.
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Drafting Cybersecurity Assessment for an implantable Brain Interchange system for paralysis and identifying threats and vulnerabilities based on the assets, evaluating risks based on CVSS scoring and providing risk mitigations as per AAMI TIR 57 and NIST 800-1 guidelines.
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Assisting in a DTAC (Digital Technology Assessment Criteria) to support NHS compliance for drafting and reviewing the main file and its supporting documentation for Magic Tasks and successfully completed.
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Currently working in a DTAC project by preparing entirely and its supporting documentation for CareApps.
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Working as a Junior Quality Manager in helping quality & regulatory compliance activities for medigital and placing their product hiToco in UK Market.
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CERTIFICATIONS
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Active RAPS member (Dec 9, 2024) - Successfully joined as a member in
Regulatory Affairs Professional Society (RAPS) for an exciting journey to learn new set
of knowledge and skills towards regulatory affairs. -
Achieved certifications from Udemy on the following standards
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ISO 27001:2022​
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IEC 62304:2006 + AMD1:2015
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ISO 13485:2016
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Certified as an Internal Auditor ISO 27001:2022 from British Assessment Bureau​
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Certified as an Lead Auditor Practitioner acccredited by BSI (Notified Body)
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CONTACT
If you want to know more about my profile and work along with me in regulatory submissions to help your medical devices/SaMD to reach market, I will help you to identify the best approach for providing regulatory strategies for easier clearance. Please feel free to reach out to me.
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Tel: +44 7490885495
Address: Flat 35, Granville House, Victoria Parade, Ramsgate, UK
CT11 8DF
Upwork profile - Ashok Sriram
