Medical Devices
CDSCO · ISO 13485 · CE
Need the right compliance path?
Find the RightCompliance PathBefore You Apply
NQSC helps medical device, pharma, healthcare, laboratory, food, and manufacturing businesses identify the right licensing, documentation, certification, validation, audit, and market-access pathway.
- End-to-End Support
- Regulation Ready
- Expert Guidance
- Audit Confidence
NQSCCompliance Pathway Hub
Medical Devices
CDSCO · ISO 13485 · CE
Pharma & GMP
WHO-GMP · COPP · Dossier
Healthcare & Labs
NABH · NABL · ISO 17025
Food & Safety
FSSAI · ISO 22000 · HACCP
Cleanroom & Validation
ISO 14644 · Process Validation
Management Systems
ISO 9001 · 14001 · 45001
WHO WE HELP
Compliance support for regulated industries
From CDSCO licensing to ISO, CE, GMP, cleanroom validation, and audit readiness, NQSC supports teams from first licence review through renewals.
Medical Device Manufacturers Medical Device Manufacturers
For Class A-D device manufacturers preparing for licensing, ISO 13485, technical files and inspection readiness.
- CDSCO
- ISO 13485
- PMF
- DMF
- Audit
Outcome: Clarity before manufacturing licence application
Importers & Indian Agents Importers & Indian Agents
Support for import licence readiness, authorised agent documentation, Power of Attorney and CDSCO coordination.
- MD-14/15
- PoA
- CDSCO
- Import File
Outcome: Cleaner import pathway and document readiness
Pharma & WHO-GMP Units Pharma & WHO-GMP Units
GMP readiness, COPP support, dossier preparation and inspection support for regulated pharma teams.
- WHO-GMP
- COPP
- Dossier
- Inspection
Outcome: Stronger readiness for GMP and export support
IVD & Diagnostic Companies IVD & Diagnostic Companies
IVD classification, performance evaluation files, technical documentation and India pathway support.
- IVD
- Performance File
- MDR 2017
- Technical File
Outcome: Better regulatory clarity for diagnostic products
Cleanroom & Manufacturing Units Cleanroom & Manufacturing Units
Cleanroom design, validation, monitoring, process validation and qualification support.
- ISO 14644
- Validation
- Monitoring
- Process
Outcome: Facility readiness for regulated manufacturing
Exporters Targeting EU / USA Exporters Targeting EU / USA
CE, EU MDR, UKCA, US FDA, clinical evaluation, risk files and market-access documentation support.
- CE
- EU MDR
- US FDA
- Risk
- CER
Outcome: Improved international documentation readiness
Common support across industries
- Pathway Mapping
- Documentation
- Validation
- Licensing
- Audit Readiness
- Post-Certification Maintenance
Not sure which pathway applies to your product or facility?
SERVICES
Regulatory, certification, and compliance services
Support for licensing, ISO certification, technical documentation, validation, audit readiness, and post-approval compliance.
- 1Plan pathway
- 2Prepare documents
- 3Validate process
- 4Support audit
- 5Maintain compliance
CDSCO & Medical Device Licensing
Outcome
Manufacturing, import, test, loan, sale and export licensing support
Pathway guidance and documentation support for medical device manufacturers, importers and Indian agents.
- MD-3/5
- MD-7/9
- MD-14/15
- MD-12/13
- MD-16/17
ISO & Certification Consulting
Outcome
Quality and management system certification readiness
Implementation and audit preparation support for medical device, quality, environment, safety, food and information security systems.
- ISO 13485
- ISO 9001
- ISO 14001
- ISO 45001
- ISO 22000
Global Regulatory Support
Outcome
Market access documentation for EU, UK, USA and international pathways
Support for CE marking, EU MDR/IVDR, UKCA, US FDA documentation, risk files and international readiness.
- CE
- EU MDR/IVDR
- UKCA
- US FDA
- GSPR
Technical Documentation
Outcome
Inspection-ready technical and regulatory files
Preparation and review support for site files, device files, clinical evaluation, risk analysis, design files and dossiers.
- SMF
- DMF
- CER
- GSPR
- Risk
- Design File
Cleanroom & Validation
Outcome
Facility, process and sterilization readiness
Cleanroom design, qualification, monitoring, process validation, sterilization validation and packaging validation support.
- ISO 14644
- ETO
- Gamma
- ISO 11135
- ISO 11607
Audit, Training & Post-Approval
Outcome
Long-term compliance control beyond certificate approval
Internal audits, supplier audits, CAPA, management review, training, surveillance readiness and license maintenance support.
- Audit
- CAPA
- MRM
- Training
- PMS
- Renewal
Covered across:
Medical Devices • Pharma • Food Safety • Healthcare • Labs • Cleanroom • Management Systems
Documents and activities:
PMF • DMF • Risk File • CER • GSPR • Validation • Audit • CAPA • MRM • PMS
Need to know which licence, certificate or documentation applies to your product?
HOW WE WORK
A clear compliance pathway from review to post-approval support
From first requirement discussion to post-approval support, NQSC provides one accountable compliance pathway with clear documentation, filing, coordination and audit-readiness support.
- 1Review
- 2Checklist
- 3Gap Review
- 4Scope
- 5Documentation
- 6Filing
- 7Coordination
- 8Audit Support
- 9Maintenance
PHASE 1
Understand & Plan
Clarify what applies before documentation begins.
- 1
Requirement Discussion
Understand product, business activity, target market and current compliance status.
- 2
Document Checklist
Provide a clear checklist for licensing, certification, validation or audit readiness.
- 3
Gap Review
Review available documents and identify missing or high-priority compliance gaps.
Output: pathway clarity, document checklist, gap priorities.
PHASE 2
Prepare & File
Build the evidence required for application and audit readiness.
- 4
Scope & Proposal
Define scope, pathway, responsibilities and support required for the case.
- 5
Documentation Preparation
Prepare technical files, forms, dossiers, QMS records and supporting documents.
- 6
Application Filing
Prepare and submit applications through the relevant regulatory or certification route.
Output: structured documents, filing package, submission support.
PHASE 3
Coordinate & Support
Support authority queries, audits and ongoing compliance.
- 7
Authority Coordination
Coordinate with regulatory authorities, auditors, certification bodies or portals.
- 8
Audit / Query Support
Address audit observations, authority queries, CAPA actions and documentation responses.
- 9
Approval & Post-Approval Support
Support maintenance, renewals, post-approval changes and compliance updates.
Output: query support, audit readiness, maintenance control.
Client receives:
- Pathway clarity
- Document checklist
- Gap priority list
- Filing support
- Audit response support
- Maintenance guidance
Not sure where your product or facility stands today?
CLIENT TRUST
What Clients Say About NQSC
Feedback from CDSCO, ISO, documentation, validation and compliance support work across India and export markets.
Trusted by regulated manufacturers, importers and compliance teams
25+ years
Compliance experience
500+ clients
Companies served
190+ ISO
Certificates supported
400+ companies
Regulatory support
Want similar clarity for your license, certification or audit requirement?
NQSC helps improve approval readiness through pathway clarity, structured documentation, audit preparation, query-response support, and communication discipline. Final regulatory or certification decisions remain with the respective authorities, notified bodies, or certification bodies.
NQSC helps with documentation, forms, technical files, application readiness, coordination, and query-response support as per agreed scope. Official submissions and declarations remain with the applicant, manufacturer, importer, or authorised agent.
Yes. NQSC can help foreign manufacturers understand Indian regulatory requirements, documentation expectations, import pathways, and authorised agent requirements.
NQSC supports medical devices, pharmaceuticals, food safety, healthcare, laboratories, cleanroom-dependent manufacturing, and management system certification requirements.
Start with a structured requirement review. NQSC reviews your product, intended use, risk class, facility status, target market, and current documents before recommending the suitable pathway.
Yes. NQSC supports post-approval changes, retention planning, surveillance audit readiness, CAPA, management review, training, and ongoing compliance maintenance.
Depending on the pathway, NQSC may review product details, intended use, manufacturing process, site information, existing licences, QMS records, labels, test reports, validation records, risk files, and technical documentation.
Need clarity before filing or certification work begins?
Before you applyBefore you fileBefore an audit
Ready to clarify your compliance route before you apply?
Share your industry, product category, current stage and compliance need. NQSC will help identify the right documentation, certification, licensing, validation or audit-readiness pathway.
- Licensing
- Certification
- Validation
- Technical Documentation
- Audit Readiness
- Post-Approval Support
Already working with NQSC? Track your application status