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Subscribe on LinkedIn Address Maven Profcon Services LLP J-House, KP Epitome, Nr. Siddhivinayak Tower, Makarba, Ahmedabad, Gujarat, India 380051 690 Little Grey St, Unit 134, London, ON N5Z 4M9, Canada contact * enquiry@mavenprofserv.com * +91-7490017774 (For Enquiry Only) * +91-7490017774 (For Enquiry Only) * +1 226 998 0460 * +1 226 998 0460 * +91 7383367774 (For Career Only) * +91 9429952147 (For Career Only) * +91 9429952147 (For Career Only) * payallotani@mavenprofserv.com (Send your resume here) Copyright © Maven Profcon Services LLP * Privacy Policy * Cookies Policy * Disclaimer | +91- 7490017774 (For Enquiry Only) +91-7490017774 (For Enquiry Only) +91 7383367774 (For Career Only) enquiry@mavenprofserv.com * * * * * Services + CE Marking Consultancy o CE Marking for Medical Device - Technical Files for Medical Devices - Risk Management for Medical Device - General Safety and Performance Requirement (GSPR) - Instruction for Use (IFU) - List Of Applicable Standards - SSCP - Medical Device Testing - Medical Device Labelling - Usability - Design History File - Stability Study o CE Marking for In Vitro Diagnostic Device (IVD) - Performance Evaluation Report - Technical File for In Vitro Diagnostic Devices (IVDs) - Risk Management for Medical Device - General Safety and Performance Requirement (GSPR) - Instruction For Use (IFU) & Labels - List Of Applicable Standards - SSP - Stability Studies of Medical Devices - Design History File - Medical Device Testing o Preparation of Clinical Evaluation for Medical Device - Clinical Evaluation Plan - Literature Search Protocol & Report - Demonstration Of Equivalence - Clinical Evaluation Report o Preparation of Post Market Surveillance Documents - PMSR - PSUR - PMCF - PMPF - Vigilance System o Notified Body Selection Service o MDD Vs MDR – Gap Analysis o European Authorized Representative (EAR) o Unique Device Identification (UDI) o European Database On Medical Devices (EUDAMED) o European Free Sale Certificate (FSC) o Medical Device (QMS) - Audit Support - Validation as per ISO 13485 + CDSCO Registration o Test License (MD – 03 & 12) o Manufacturing License (MD – 05, 07 & 09) o Import License (MD – 15) o Free Sales Certificate (FSC) + UKCA Certification Consultancy o UKCA Mark Certification Consultation for Medical Devices o Technical Documentation For UKCA Mark o MHRA Registration for Medical & IVD Devices o UK Responsible person + US FDA 510(k) o US FDA 510(k) for Medical & IVD Devices o FDA 510(k) Submission: A Comprehensive Guide o Drug Establishment Registration o Registration and Listing of Medical Device o US Agent Services o US FDA Label Review + Other Regulatory Services o Country Registrations o MDSAP o Annual Maintenance Contract o Premium Organizational Management Services o Internal Quality Audit o Training o Validation o Integrated Quality Management System - Management Review Meeting o ISO 13485 o Benefit – Risk Analysis o Biological Evaluation o Safety Performance Testing * About Us * Pricing * Blogs * Careers * Contact Us * enquiry@mavenprofserv.com * 079-40026222 * +91-7490017774 (For Enquiry Only) * +91 7383367774 (For Career Only) * * * * * Search for: Template Don’t know where to start with regulations? Learn from the Experts Read Our Blogs 1. 2. Blogs * Dec 25, 2025 Maven FDA 510(k) Consultants For Medical Devices Dec 25, 2025 Maven European CE Marking for Medical Devices Dec 23, 2025 Maven Decoding CAPA in MDSAP: Your QMS’s Most Critical Pulse Check Dec 10, 2025 Maven Post Market Surveillance & Vigilance: A Closer Look at MDSAP Requirements Nov 26, 2025 Maven How to Get Your Medical Device Approved in Canada: Key Regulatory Insights Nov 12, 2025 Maven Modernizing Audits: Insights from the MDSAP Remote and Hybrid Pilot Program Oct 9, 2025 Maven MDSAP Audit Checklist: How to Prepare for a Successful Audit Oct 8, 2025 Maven Understanding MDSAP Audit Structure and Process Oct 1, 2025 Maven Purpose of a Clinical Evaluation under the EU MDR Sep 13, 2025 Maven ISO 13485 Certification Consultants for Medical Device QMS (MD-QMS) 1 2 3 … 14 Next » Tags * CE for In Vitro Diagnostic Device * CE Marking * Clinical Evaluation * Clinical Evaluation Plan * Clinical Requirements * EUDAMED * In-Vitro Diagnostic Medical Device * Medical Device * Medical Device Business * medical device risk management * Medical Devices Regulation * Periodic safety update report * Post Market Surveillance Report * PSUR * Regulatory Affairs * Risk Analysis * Risk Evaluation * Risk Management * Risk management for medical device Recent Post December 25th, 2025 FDA 510(k) Consultants For Medical Devices December 25th, 2025 European CE Marking for Medical Devices December 23rd, 2025 Decoding CAPA in MDSAP: Your QMS’s Most Critical Pulse Check Share with * * * * Are You Looking For Medical Devices Certifications? Contact Us Maven Profcon Services LLP offers expert medical device regulatory consulting services, helping medical device manufacturers meet global regulatory requirements with confidence. * Home * About Us * Pricing * Blogs * Career * Contact Us * Templates * * * * Services * * CE CERTIFICATION CONSULTANCY FOR MEDICAL DEVICE + CE Consultancy for Medical Devices + CE Consultancy for In vitro diagnostic Devices (IVDs) + Clinical Evaluation for Medical Devices + Post Market Surveillance (PMS) for IVDs + Performance Evaluation For IVDs + Post-Market Clinical Follow-up (PMCF) for Medical Devices + Post Market Surveillance Report (PMSR) for Medical Devices + Periodic Safety Update Report (PSUR) for Medical Devices * * CDSCO APPROVALS FOR MEDICAL DEVICES + Test License for Medical Devices + Manufacturing License for Medical Devices + Import License for Medical Devices * * US FDA 510(k) APPROVAL CONSULTANCY + US FDA 510(k) + Establishment Registration and Device Listing + US Agent Service * * UKCA CERTIFICATION REGULATORY CONSULTANCY + UKCA Marking for Medical Devices/IVDs + UK Responsible Person + MHRA Registration * * OTHER REGULATORY CONSULTANCY + Country Registration + MDSAP + Annual Maintenance Contract + Internal Quality Audit + Training + Validation + ISO 13485 Consultants CE CERTIFICATION CONSULTANCY FOR MEDICAL DEVICE * CE Consultancy for Medical Devices * CE Consultancy for In vitro diagnostic Devices (IVDs) * Clinical Evaluation for Medical Devices * Post Market Surveillance (PMS) for IVDs * Performance Evaluation For IVDs * Post-Market Clinical Follow-up (PMCF) for Medical Devices * Post Market Surveillance Report (PMSR) for Medical Devices * Periodic Safety Update Report (PSUR) for Medical Devices CDSCO APPROVALS FOR MEDICAL DEVICES * Test License for Medical Devices * Manufacturing License for Medical Devices * Import License for Medical Devices US FDA 510(k) APPROVAL CONSULTANCY * US FDA 510(k) * Establishment Registration and Device Listing * US Agent Service UKCA CERTIFICATION REGULATORY CONSULTANCY * UKCA Marking for Medical Devices/IVDs * UK Responsible Person * MHRA Registration OTHER REGULATORY CONSULTANCY * Country Registration * MDSAP * Annual Maintenance Contract * Internal Quality Audit * Training * Validation * ISO 13485 Consultants Stay Updated with Our LinkedIn Newsletter Join our LinkedIn newsletter for the latest updates on medical device regulations! Subscribe on LinkedIn Address Maven Profcon Services LLP J-House, KP Epitome, Nr. Siddhivinayak Tower, Makarba, Ahmedabad, Gujarat, India 380051 690 Little Grey St, Unit 134, London, ON N5Z 4M9, Canada contact * enquiry@mavenprofserv.com * +91-7490017774 (For Enquiry Only) * +91-7490017774 (For Enquiry Only) * +1 226 998 0460 * +1 226 998 0460 * +91 7383367774 (For Career Only) * +91 9429952147 (For Career Only) * +91 9429952147 (For Career Only) * payallotani@mavenprofserv.com (Send your resume here) Copyright © Maven Profcon Services LLP * Privacy Policy * Cookies Policy * Disclaimer |
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