End-to-End Regulatory Compliance and Certification Support
Key Standards for compliance
Simplifying Regulatory Complexity
for
Med Tech Innovators
Med Tech Company
Regulatory complexity can be overwhelming for Medical devices, In-Vitro Diagnostics, Software as a Medical device (SaMD) Innovators, Importers, and Manufacturers.
Problem
A single misstep in classifying your medical device, or documentation can delay marketentry by months to years. These timelines can affect investor confidence, disrupt commercial launches, and create costly compliance gaps.
we are here to help you navigate every checkpoint
-
Risk
Classification - QMS
- Design
- Prototype
- Testing
-
Clinical
Evaluation -
Dossier
Preparation - Submission
- Licensing
About Us
We provide comprehensive certification, regulatory, and compliance support for medical devices, IVDs, and software as medical devices (SaMD).
From regulatory strategy to post-market surveillance our experts ensure faster approvals across India, Europe, and the USA.
We also support startups and innovators who are new to the regulatory landscape from feasibility assessment and classification strategy to prototype testing and approval.
For established importers, we manage large portfolios, renewal timelines, change notifications, and authority interactions through a dedicated regulatory project manager, with Ai solutions.
Regions we support
We support innovation across diverse sectors with tailored compliance and testing solutions.
CDSCO
Overview
India is one of key developing market contributing for imports and exports of Medical Device. The Central Drug Standard Control Organization (CDSCO) is a regulatory body which regulates Drugs, Cosmetics, medical devices and In-Vitro Diagnostics (IVD) marketed in India.
All the applications for both Notified and Non-notified devices must be submitted through online portal called SUGAM and the manages the applications through the same portal.
We provide end-to-end CDSCO consulting support for Medical Devices, IVDs, and Software as a Medical Device (SaMD), ensuring your products meet India’s Medical Device Rules (MDR 2017) and Central Drugs Standard Control Organization (CDSCO) requirements from classification to license approval.
Our expert team can help in simplifying complex regulatory pathways, guide you in the design optimal pathway, reduce time to approval, assist you to move from concept to commercialization efficiently and confidently while ensure full compliance with CDSCO requirements.
Our Core Services
- SUGAM account creation and account management
- Liaison with the CDSCO, Central and State Licensing Authorities (CLA and SLA)
- Assessment of device intended use, technology, and global approvals
- Preparation of Classification Request Document (CRD)
- Advisory on applicable CDSCO forms, license types, and timelines
- Medical Device Classification and grouping strategy
- Regulatory Gap Assessment to identify missing data, required documents and compliance risks and provide guidance, suggestions.
- Regulatory Intelligence and Due-Diligence services in India
- Dossiers Preparation and submission for Test license
- Coordination with labs and test facilities, guidance and review support for preclinical and validation documents.
- In-country Testing services
- Execute testing, EMC, Electrical safety as per the standards.
- Review and guide Clinical Investigation Plan (CIP), Investigators Brochure (IB), and informed consent forms (ICF)
- Coordination with Ethics Committee (EC) and CROs clinical trail
- GCP and ISO 14155 documentation support
- Technical file & Device Master File (DMF) compilation
- Risk management, performance data, and safety summary preparation
- Submission, query management, and follow-up with CDSCO
- Complete support for QMS implementation per ISO 13485 or as per Schedule 5 of MDR 2017
- Labeling Compliance to MDR 2017 Labelling requirements
- Preparation of Plant Master File (PMF) and Plant Audit Readiness
- Liaison during CDSCO audit and post-approval compliance
- For global manufacturers seeking India market entry
- Dossier preparation aligned with predicate device or PMA approval data
- Authorized Indian Representative (AIR) services
CE Marking (EU)
Confidently access the European Market.
Why CE Marking
To market medical devices,In Vitro Diagnostics, and Software as a Medicaldevices (SaMD) in theEuropean Union, manufacturers must demonstrate compliance with the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746).
A CE Mark is a proof of safety,performance, and regulatory compliance.
Our expertise includes:
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
- Regulatory roadmaps, milestoneplanning and budgetestimates.
- Expert identification and classification of your medicaldevices, IVD devices,and SaMD as per the EU MDR or EU IVDR classification rules.
- Prepare your Regulatory Strategy and roadmapto CE Marking.
USFDA
Regulatory Consulting Services
Your Trusted Partner for your Medical devices, IVD devices - 510(k), De Novo, PMA, and SaMD Submissions
- Regulatory Affairs & Regulatory Intelligence
- Regulatory Consulting and Market Access Roadmap
- Registration Pathways and License Management
- Regulatory Submissions
- Artwork & Regulatory Labeling
- Packaging compliance Management
- Medical and Scientific Writing
With the right consulting partner and knowledgeable staff, navigating the US FDA medical device regulatory complex environment doesn’t have to be difficult or time-consuming.
We offer end-to-end FDA regulatory consulting for medical devices, IVDs, and digital health solutions, helping you achieve faster and compliant market entry. Our experts guide you through the entire FDA submission lifecycle, from device classification and testing to clearance, approval, and post-market compliance.
Our expertise includes:
- Determine device classification (Class I, II, or III), or support in Classification request 513 (g)
- Identify appropriate regulatory pathway, 510(k), De Novo, or PMA
- Predicate device analysis and regulatory strategy mapping
- Review and support for preparation of intended use, indications for use, and labeling
- Full preparation and compilation of Traditional, Abbreviated, or Special 510(k)
- Predicate comparison and substantial equivalence justification
- Coordination for bench testing, biocompatibility, software, and EMC requirements
- Interaction with FDA reviewers and response to deficiency letters
- Preparation of De Novo request documentation for novel low/moderate-risk devices
- Risk-benefit assessment, clinical justification, and special control proposals
- End-to-end support through FDA review and classification grant
- Strategic planning and preparation of PMA applications for Class III devices
- Clinical evidence compilation, statistical review, and manufacturing information
- SaMD classification and Pre-Submission (Q-Sub) guidance
- Compliance with FDA’s Digital Health Framework and AI/ML device guidance
- Software validation (IEC 62304), cybersecurity (FDA premarket guidance), and HIPAA alignment
- Support for Clinical Decision Support (CDS) and real-world data strategies
We Provide End-to-End Solutions for Your Products Under One Roof
We also offer Testing , Design and Development Services
Testing
Every product undergoes rigorous compliance testing for performance, safety, and reliability. We evaluate your design through EMC testing, electrical safety testing, thermal and vibration tests, and environmental stress simulations.
Certification
Navigating certifications is easy with our end-to-end support. We assist in achieving regional and international compliance, including BIS, CE, FCC, RoHS, WPC certifications and more.
Product Design
We specialize in electronics design, hardware design, and mechanical enclosures to transform your innovative idea into a fully functional prototype.
Ready to get certified?
