Approval in 5 Moves

CE Mark
01

Identify Regulatory Pathway

CE Mark
02

Gap Analysis

CE Mark
03

Perform Required Testing

CE Mark
04

Support Drafting Technical Documents

CE Mark
05

File Certification

Services

Overview

At NexorTest, we provide complete CE marking certification support for MedTech devices, Software as a Medical Device (SaMD), IoT products, commercial electronics, and industrial electrical equipment. Our end-to-end compliance solutions include certification planning, technical documentation, EMI/EMC, RF, and wireless testing, as well as ISO 13485 compliance and labeling guidance. With our expertise, your products meet all relevant EU directives and are ready for fast, hassle-free market entry in Europe and beyond.

  • Machinery Directive – 2006/42/EC
  • Low Voltage Directive - 2014/35/EU
  • Medical Devices Directive - 93/42/EEC
  • EMC Directive – 2014/30/EU
  • REACH – Regulation (EC) No 1907/2006
  • RoHS – Restriction of Hazardous Substances – Directive 2011/65/EU
  • Waste Electrical and Electronic Equipment (WEEE) Directive – 2012/19/EU
  • Active Implantable Medical Devices Directive – 90/385/EEC
  • Radio Equipment Directive (RED)
  • Roadmap to certification
  • Gap analysis and compliance assessment
  • Technical documentation preparation
  • EMI/EMC testing
  • RF and wireless performance testing
  • Biocompatibility testing
  • Technical dossier compilation
  • ISO 13485 compliance documentation
  • Product labeling and marking support

Overview

At NexorTest, we provide complete FCC certification support for MedTech electronics, automotive electronics, IoT devices, commercial electronics, and wireless equipment. Our expertise focuses on FCC Part 15 and Part 18 compliance testing, covering intentional and unintentional radiators, wireless modules, and industrial, scientific, and medical (ISM) devices. We guide the entire FCC approval process — from compliance planning and documentation to EMI/EMC, RF testing, and labeling — ensuring your products meet U.S. market entry requirements quickly and efficiently.

  • FCC Part 15 – Radio Frequency Devices (Intentional and Unintentional Radiators)
  • FCC Part 18 – Industrial, Scientific, and Medical Equipment (ISM)
  • FCC Rules for Wireless Modules
  • FCC Equipment Authorization Procedures
  • RF Exposure and SAR Requirements
  • Labeling and User Manual Compliance per FCC Guidelines
  • FCC compliance roadmap
  • Gap analysis and pre-compliance evaluation
  • Technical documentation preparation
  • EMI/EMC testing as per FCC requirements
  • RF and wireless performance testing
  • SAR and RF exposure assessment
  • Test report preparation and submission
  • Product labeling and FCC ID support

Overview

At NexorTest, we offer end-to-end certification support for the Indian market covering BIS, WPC, and TEC approvals for electronic products and IoT devices. Our services ensure your products meet mandatory regulatory requirements for sale and import into India. From compliance roadmap planning and gap analysis to product testing, documentation, and liaison with certification bodies, we manage the entire process so you can focus on launching your product faster. Whether it’s consumer electronics, industrial electronics, or connected IoT solutions, we ensure smooth and hassle-free compliance.

  • BIS – Bureau of Indian Standards – Compulsory Registration Scheme (CRS) for electronics
  • WPC – Wireless Planning & Coordination – ETA and licensing for wireless devices
  • TEC – Telecommunication Engineering Centre – Mandatory Testing & Certification of Telecom Equipment (MTCTE)
  • Safety and performance standards for electronic products
  • RF and spectrum compliance for wireless devices
  • Environmental and material compliance as per Indian regulations
  • Compliance roadmap and planning
  • Gap analysis and regulatory requirement mapping
  • Technical documentation preparation
  • Product testing as per Indian standards
  • RF and wireless testing for WPC approval
  • Submission of applications to BIS, WPC, and TEC
  • Certification follow-up and liaison with authorities
  • Product labeling and marking compliance

Overview

At NexorTest, we provide complete CDSCO certification support for medical devices, in-vitro diagnostic devices, and Software as a Medical Device (SaMD) in India. Our services ensure compliance with the Medical Device Rules (MDR) 2017 under the Central Drugs Standard Control Organization (CDSCO). From identifying the correct device classification to preparing regulatory documentation, coordinating testing, and managing the approval process, we help you navigate India’s medical device regulatory pathway with speed and precision. Whether you are introducing a new device or updating existing registrations, our end-to-end solutions ensure a smooth pathway to market.

  • Medical Device Rules (MDR) 2017 – All classes (A, B, C, D)
  • In-Vitro Diagnostic (IVD) Device Regulations
  • Software as a Medical Device (SaMD) Guidelines
  • Import and Manufacturing Licensing under CDSCO
  • Post-Market Surveillance and Adverse Event Reporting
  • Labeling and Packaging Compliance for Medical Devices
  • Device Master File (DMF) and Plant Master File (PMF) Requirements
  • Device classification and regulatory pathway mapping
  • Gap analysis of technical and quality documentation
  • Preparation of Device Master File (DMF) and Plant Master File (PMF)
  • Technical documentation and risk management files
  • Clinical evaluation reports and performance data compilation
  • Product testing coordination as per BIS/ISO/IEC standards
  • Application submission and liaison with CDSCO
  • Labeling, packaging, and UDI compliance support
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