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Service Categories

• CDSCO Compliance Medical Devices & IVDs
• USFDA Compliance US Market Access
• BIS Certification ISI, CRS, FMCS & Scheme X
• EPR & LMPC Registration
• Food & Ayush Compliance
• International Certifications
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CDSCO Compliance

• CDSCO Medical Device Registration in India
• CDSCO Import Registration (Form MD-15)
• CDSCO Manufacturing License for Medical Devices
• CDSCO Test License for Medical Devices
• CDSCO IVD Import Registration in India
• Medical Device Design & Development
• Cosmetics CDSCO Import Registration
• IVD Registration in India
• Medical Device Project Report Preparation

USFDA Compliance

• FDA 510(k) Documentation & Submission
• USFDA Regulatory Strategy & Device Assessment
• USFDA Product Listing & Establishment Registration
• FDA Accession Number & Radiation Reports
• FDA for Software as a Medical Device (SaMD)

Quality Management System

• ISO 13485 Certification for Medical Devices
• FDA 21 CFR Part 820 Quality System
• MDSAP Certification Consulting
• ISO 15378 Certification for Primary Packaging
• QMS Software (eQMS) Consulting
• Primary Packaging Regulatory Consultant

Regulatory Services

• CE Marking for Medical Devices
• SFDA Medical Device Registration
• UKCA Marking for Medical Devices

Turnkey Project Consultant

• Medical Device Detailed Project Report (DPR)
• Medical Device Manufacturing Facility Layout
• Medical Device Validation Documentation
• Medical Device Clean Room Consultant
• Medical Device QMS (Quality Management System) Setup
• Medical Device Regulatory Services
• ISO Standards for Medical Devices & IVDs

BIS Certification

• BIS ISI Certification for Domestic Manufacturers
• BIS FMCS Certification for Foreign Manufacturers
• BIS CRS Registration for Electronics
• BIS Scheme X Certification
• BIS Certification for Paver Blocks
• BIS Certification for Furniture
• BIS Certification for Home Appliances

EPR / LMPC Registration

• EPR Registration for Plastic Waste
• EPR Registration for Battery Waste
• EPR Registration for E-Waste
• EPR Registration for Waste Tyres
• Legal Metrology (LMPC) Product Compliance
• LMPC Legal Metrology for Weighing Scales

Food & Ayush

• Nutraceutical & Health Supplement Compliance
• Plant Setup as per CGMP
• FSSAI Product Approval

International Certifications

• WPC / ETA Approval for Wireless Products
• TEC Approval (MTCTE) for Telecom
• RDSO Vendor Registration
• PESO Certification & Licensing
• CE Marking Certification
• SFDA Registration for Saudi Arabia

Testing Facility

• Lithium-Ion Battery Testing
• RF Testing for Wireless Products
• IP Rating Testing
• NABL Approved Testing
• IAF Accredited Testing & Certification

Industries

• Medical Device Industry
• Pharmaceutical Industry
• Cosmetic Industry
• Food Industry
• Environmental Industry
• Chemical Industry

Resources

• Blog
• Case Studies
• Regulatory Updates

Blog Posts

• Top 10 BIS-ISI Consultants in India (2026)
• Top 20 CDSCO Licensing Consultants in India (2026)
• BIS Consultation in India: A Complete Guide to Certification, Compliance, and Approval for Manufacturers, Importers, and MSMEs
• Top CDSCO Cosmetic Import Registration in India | Complete COS-1 & COS-2 Guide for Importers | MedregX India
• CDSCO License for Dental Medical Devices in India: Registration, Import & Manufacturing Guide | MedRegX India
• X-Ray Machine CDSCO Registration in India – Import License Guide 2026 | MedregX India
• Medical Device Registration in India for Class A, B, C & D Devices | CDSCO Compliance Guide 2026
• BIS Certification for Toys in India | ISI Mark for Toys under IS 9873
• BIS Certification for Concrete Paver Blocks IS 15658:2021 | ISI Mark Consultant India

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