NQSCQUALITY · COMPLIANCE · TRUST
Founder-led compliance advisory
Since 2000

Practical regulatory guidance backed by decades of audit, licensing and certification experience

NQSC helps organizations plan the right compliance pathway, prepare technical documentation, obtain licenses, support audits, validate facilities and maintain long-term regulatory readiness.

Medical Devices • Pharma • Food Safety • Healthcare • Labs • Management Systems

Founder credentials

Compliance dossier

R. S. Mishra

Founder & CEO

Medical Device Regulatory & Certification Consultant

  • ISO 13485
  • ISO 14971
  • EU MDR
  • CDSCO
  • MDSAP
  • ICMED

Regulatory support · Certification · Licensing · Validation · Audit readiness

  • 25+Years Experience
  • 400+Companies Supported
  • 1000+Audit Mandays
  • Multi-sectorCompliance Coverage
  • India + OverseasSupport

FOUNDER PROFILE

R. S. Mishra, Founder and CEO of NQSC25+ Years Experience

R. S. Mishra

Founder & CEO

Medical Device Regulatory & Certification Consultant

  • ISO 13485
  • ISO 14971
  • EU MDR
  • CDSCO
  • MDSAP
  • ICMED

Led by practical regulatory and quality-system experience

Mr. R. S. Mishra brings hands-on depth across medical device QMS, licensing, technical files, cleanroom and sterilization validation, CE marking, EU MDR, ISO 14971 and audit readiness for regulated manufacturers and exporters.

  • Mechanical Engineering Background

  • Lead Auditor: ISO 9001:2015 QMS

  • Lead Auditor: ISO 14001:2015 EMS

  • Food Safety, HACCP and ISO 22000

  • ISO 13485:2016 Medical Device QMS

  • EU MDR, ISO 14971, MDSAP and ICMED Exposure

PROFESSIONAL JOURNEY

Built through manufacturing, quality leadership and regulatory practice

  1. Foundation

    Industrial foundation

    Manufacturing discipline, production controls and early quality-system exposure.

  2. Leadership

    Quality assurance leadership

    QA systems, inspection readiness and plant coordination across regulated operations.

  3. Plant leadership

    Regulatory and plant leadership

    Facility controls, documentation governance and compliance-led plant leadership.

  4. Specialisation

    Medical device documentation expertise

    Technical files, licensing routes, validation and international regulatory alignment.

  5. Today

    Independent consultancy and training

    Licensing, certification, audit preparation, training and post-certification support.

WHY NQSC

Practical compliance experience across factory setup, technical files, validation, licensing and audit readiness

NQSC's strength is not limited to documentation. The team brings hands-on experience across regulated manufacturing, cleanroom controls, sterilization validation, risk management, product compliance and audit preparation.

Regulatory Pathway

CDSCO, State FDA, ONDLS, NSWS, CE / EU MDR

Facility & Process

Plant setup, cleanroom, ETO, Gamma, process validation

Technical Documentation

PMF, DMF, risk analysis, CER, GSPR, labeling

Audit & Maintenance

Internal audit, CAPA, MRM, PMS, post-certification support

  • Plant Setup & Facility Readiness

    Build the facility around compliance from day one

    Guidance across plant setup, cleanroom planning, production flow, hygiene controls and compliance-led facility readiness.

    • Cleanroom
    • ISO 14644
    • Schedule M
    • Facility Controls

  • Sterilization & Validation Depth

    Validation support for regulated manufacturing

    Support for ETO, Gamma, process validation, packaging validation, cleaning validation and microbial control.

    • ETO
    • Gamma
    • ISO 11135
    • ISO 11137
    • ISO 11607

  • Medical Device QMS Implementation

    Quality systems aligned to device risk and regulation

    ISO 13485, MDQMS, documentation governance, internal audits, CAPA and management review support.

    • ISO 13485
    • MDQMS
    • CAPA
    • MRM
    • Internal Audit

  • Technical File & Regulatory Documentation

    Documentation that supports licensing and audits

    Preparation and review support for PMF, DMF, risk analysis, clinical evaluation, GSPR/ER reports, labeling and post-market records.

    • PMF
    • DMF
    • Risk
    • CER
    • GSPR
    • Labeling

  • Product Risk & Safety Compliance

    Product safety evidence for regulated markets

    Support across ISO 14971 risk management, ISO 10993 biocompatibility, IEC 60601 electrical safety and performance documentation.

    • ISO 14971
    • ISO 10993
    • IEC 60601
    • Safety
    • Performance

  • Audit, Training & Long-Term Maintenance

    Compliance control beyond certificate approval

    Internal audit planning, supplier audits, training, surveillance readiness, license maintenance and post-certification support.

    • Training
    • Supplier Audit
    • PMS
    • Surveillance
    • Maintenance

Supported across medical disposable devices, ophthalmic devices, electro-medical devices, dental devices, surgical blades, scientific plastic consumables and cleanroom-dependent products.

EXPERTISE

Expertise across regulated industries

Select a pathway to review typical scope, documentation support, regulatory touchpoints and readiness activities.

Medical Device Licensing

Pathway support

CDSCO licensing pathways, technical documentation, import and manufacturing readiness, and license maintenance support.

Typical scope

  • Manufacturing license support
  • Import license support
  • Test license support
  • Loan license support
  • Post-approval change and retention support

Documents handled

  • Plant Master File
  • Device Master File
  • Test protocol
  • Label and IFU support
  • Risk and technical documentation

Regulatory touchpoints

  • CDSCO
  • State FDA
  • NSWS
  • ONDLS
  • IMDR 2017

Best suited for

  • Medical device manufacturers
  • Importers
  • Startups preparing product launch
  • Companies adding new device categories
  • MD-3/5
  • MD-7/9
  • MD-14/15
  • MD-12/13
  • MD-16/17
  • MDQMS
View related services

CREDENTIALS

Credentials and training evidence

Professional certifications and training supporting audit, medical device, regulatory and quality-system practice. Certificate numbers are not displayed publicly.

  • Lead Auditor Credentials
  • Medical Device QMS
  • Risk Management
  • EU MDR Exposure
  • MDSAP & ICMED
  • Food Safety & HACCP
  • Verified credential

    ISO 13485:2016 Medical Device QMS

    Medical device quality management system training and audit exposure

    • ISO 13485
    • MDQMS
    • Internal Audit
    • Medical Devices

    Relevant for device manufacturers, technical files, QMS readiness and audit preparation.

  • Verified credential

    ISO 14971:2019 Risk Management

    Risk management for medical devices

    • Risk Analysis
    • Hazard Control
    • Safety
    • Technical File

    Relevant for product risk files, clinical evaluation support and regulatory submissions.

  • Verified credential

    EU MDR, MDSAP & ICMED

    International and Indian medical device compliance exposure

    • EU MDR
    • MDSAP
    • ICMED
    • CE Marking

    Relevant for international readiness, CE documentation and certification planning.

  • ISO 9001:2015 QMS Lead Auditor

    QMS

    Quality management audit planning, process control and continual improvement.

  • ISO 14001:2015 EMS Lead Auditor

    EMS

    Environmental management system audit and compliance control.

  • ISO 22000 / HACCP / FSMS

    Food Safety

    Food safety systems, hazard analysis and operational prerequisite programs.

  • ISO 45001 / OHSMS

    OHSMS

    Occupational health and safety management system readiness and audit support.

  • ISO 13485 Internal Auditor

    MDQMS

    Medical device QMS internal audit execution and inspection preparation.

  • CE Marking / EU MDR Training Exposure

    EU MDR

    CE documentation context, EU MDR awareness and export compliance planning.

Credentials are presented for capability context. Full evidence can be reviewed during formal engagement where required.

CONSULTANCY EXPERIENCE

Practical consultancy across regulated product categories

Support across sterile and non-sterile devices, electro-medical products, consumables, ophthalmic devices, dental products and sterilization-dependent manufacturing.

  • Sterile and non-sterile disposable medical devices

    • MDQMS
    • Packaging
    • Sterility
    • Labeling

  • Ophthalmic devices and surgical instruments

    • IOL
    • Blades
    • Instruments
    • Technical File

  • Electro-medical devices

    • IEC 60601
    • Risk
    • Safety
    • Performance

  • Dental and orthodontic devices

    • ISO 10993
    • Risk
    • Material
    • Labeling

  • Surgical blades, scalpels and sterile products

    • Gamma
    • Packaging
    • Bioburden
    • Batch Release

  • Scientific plastic consumables

    • Pharma
    • Diagnostics
    • Lab Use
    • QMS

  • Cleanroom and sterilization-dependent products

    • ISO 14644
    • ETO
    • Gamma
    • Monitoring

Experience across plant setup, validation, licensing, technical documentation, risk management and audit preparation.

  • ISO 13485
  • ISO 14971
  • ISO 10993
  • ISO 11607
  • ISO 14644
  • ISO 11135
  • ISO 11137
  • IEC 60601
  • CE / EU MDR
  • IMDR 2017

Not sure which compliance path applies to your product?

MISSION & PROMISE

How NQSC approaches compliance

NQSC focuses on understanding the product, process, facility, risk class and regulatory pathway before recommending documentation, licensing, validation or certification work.

Mission

To help organizations build reliable, inspection-ready and internationally aligned compliance systems through practical guidance, technical documentation, regulatory coordination, audit support and long-term quality improvement.

Promise

NQSC does not treat certification as a one-time document activity. We understand the product, process, facility, risk class, documentation gaps and regulatory pathway before recommending the right compliance approach.

Our compliance working method

  1. Step 01

    Understand Product & Facility

    Review product category, intended use, risk class, manufacturing process, facility status and current documentation.

  2. Step 02

    Map Regulatory Pathway

    Identify applicable licensing, certification, validation, testing, labeling and audit requirements.

  3. Step 03

    Prepare Evidence & Documentation

    Structure PMF, DMF, SOPs, risk files, validation records, labeling, clinical evidence and audit records.

  4. Step 04

    Support Audit & Maintenance

    Support submission readiness, inspection preparation, CAPA, management review, surveillance audits and post-certification maintenance.

Before you apply, NQSC helps you clarify:

  • Applicable pathway
  • Required documents
  • Validation gaps
  • Audit readiness
  • Maintenance plan

Need clarity before you apply for a license, certification, audit or regulatory submission?

Speak with NQSC's compliance team and identify the right pathway before documentation, testing or application work begins.

Call NQSC at +91 98102 36683