DKNSB Medical Device Consultants
Consultancy firm providing regulatory, quality and technical services to medical device manufacturers. Services cover Indian, EU and US regulatory pathways, QMS implementation and certification support, facility design for manufacturing, document drafting for regulatory submissions, UDI/regulated master-data management, validation and testing guidance, and authorized‑representative/import registration services.
Industries
Nr. of Employees
small (1-50)
DKNSB Medical Device Consultants
#78, First Floor, Pocket J, Sector 4, DSIDC Industrial Area, Bawana-110039, New Delhi, INDIA
Products
Technical Support for Medical Device Manufacturers
Provides technical assistance to medical device manufacturers to ensure product compliance and functionality.
Regulatory Support for Medical Device Manufacturers
Assists medical device manufacturers in navigating regulatory requirements and compliance processes.
Technical Support for Medical Device Manufacturers
Provides technical assistance to medical device manufacturers to ensure product compliance and functionality.
Regulatory Support for Medical Device Manufacturers
Assists medical device manufacturers in navigating regulatory requirements and compliance processes.
Services
Consulting for import registration, sugam, MD form submissions, and manufacturing license applications with CDSCO and state authorities.
Gap analysis, remediation planning, technical documentation review, clinical evaluation support and EUDAMED/UDI compliance assistance for EU market entry.
Support for 510(k) dossier preparation, facility registration, device listing and QSR (21 CFR 820) compliance including audit training.
QMS gap assessments, SOP/document control implementation, design controls, DHF creation and readiness audits for ISO 13485 and MDSAP.
Drafting of risk management files, clinical evaluation reports, technical files, device master files, validation plans and protocols, and 510(k) dossiers.
Design of cleanrooms, HVAC and sterile processing environments, laboratories and production layouts for device manufacturing compliance.
Consulting for import registration, sugam, MD form submissions, and manufacturing license applications with CDSCO and state authorities.
Gap analysis, remediation planning, technical documentation review, clinical evaluation support and EUDAMED/UDI compliance assistance for EU market entry.
Support for 510(k) dossier preparation, facility registration, device listing and QSR (21 CFR 820) compliance including audit training.
QMS gap assessments, SOP/document control implementation, design controls, DHF creation and readiness audits for ISO 13485 and MDSAP.
Drafting of risk management files, clinical evaluation reports, technical files, device master files, validation plans and protocols, and 510(k) dossiers.
Design of cleanrooms, HVAC and sterile processing environments, laboratories and production layouts for device manufacturing compliance.
Expertise Areas
- Medical device regulatory compliance (India, EU, US)
- Quality management systems and certification (ISO 13485, MDSAP)
- Regulatory dossier and technical documentation preparation (510(k), CE technical files, device master files)
- Unique Device Identification (UDI) and master-data management
Key Technologies
- Unique Device Identification (UDI) systems
- Quality Management System (QMS) implementation and auditing
- Regulatory dossier preparation methodologies (510(k), CE technical file)
- Sterilization validation methods (ETO, gamma, moist heat)
News & Updates
Workshop-style training on ISO 14971 risk management lifecycle, tools and techniques including FMEA and fault tree analysis, and integration into QMS.
Overview of services for medical device manufacturers in India, including factory layout, licensing, import registration, QMS implementation, clinical evaluation and regulatory consultancy.
States 20 years of experience providing technical and regulatory support to medical device manufacturers.
Workshop-style training on ISO 14971 risk management lifecycle, tools and techniques including FMEA and fault tree analysis, and integration into QMS.
Overview of services for medical device manufacturers in India, including factory layout, licensing, import registration, QMS implementation, clinical evaluation and regulatory consultancy.
States 20 years of experience providing technical and regulatory support to medical device manufacturers.