Consulting services for Medical Devices including MDSW, SaMD, DTx and AI/ML-Enabled solutions
Medigear Innovations was founded to address the growing need for expertise in the dynamic field of Medical Devices, particularly focusing on Medical Device Software (MDSW), Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and AI/ML-enabled solutions. We employ a pragmatic and structured approach to streamline the path to market, minimizing burdens without compromising on our top priorities: patient safety and product quality.
We provide the following consultation services:
Clinical Development
Ensuring the safety and effectiveness of your medical device through sufficient clinical evidence and high-quality clinical data has never been more crucial. With our extensive experience in both pre-clinical and clinical domains, Medigear Innovations is equipped to support your Clinical Development efforts across the board.
Services include:
Clinical Development and Clinical Strategy
Review & Medical Writing
Clinical Evaluation Plan (CEP)
Clinical Development Plan (CDP)
Literature Search, Review and Reporting
Clinical Evaluation Report (CER)
Post-Market Clinical Follow-up (PMCF)
Clinical Investigation and Good Clinical Practice (GCP)
Product Expertise
Despite being specialist within the domain of Software-enabled Medical Devices, we have solid working knowledge within a wide array of different device types, categories and classes.
Working knowledge include:
Medical Device Software (MDSW)
Software as a Medical Device (SaMD)
Software in a Medical Device (SiMD)
Digital Therapeutics (DTx)
AI/ML-Enabled Medical Devices
Combination Products
In Vitro Diagnostic (IVD) Medical Devices
Regulatory Affairs
Whether you are seeking FDA approval, CE or UKCA marking, we provide Regulatory Support for both development, submission and post-market activities and help you efficiently communicate with regulatory authorities.
Services include:
Regulatory Strategy and Submission
Classification and path to market
Developing Intended Use / Intended Purpose
Person Responsible for Regulatory Compliance (PRRC)
Gap Analysis and Process Mapping (As-is & To-be)
The European MDR (EU) 2017/745
The European IVDR (EU) 2017/746
The Artificial Intelligence Act ('AI Act')
The UK MDR 2002 (SI 2002 No 618, as amended)
The FDAs 21 CFR, Part 820 (the 'QSR')
Quality Assurance
A crucial strategy to reduce overhead and boost product value is by streamlining your product and internal processes to be LEAN, without compromising on quality. At Medigear Innovations, we support this effort by offering assistance in Quality Management System (QMS) development and Design Assurance, ensuring your operations are efficient yet adhere to the highest standards of quality.
Services include:
• Review of technical documentation & Gap-analysis
• Technical Writing
• QMS Development and Optimization
• Internal Audits and preparation
• Design Controls
• Risk Management
• Requirements Engineering / Management
• Human Factors / Usability Engineering
• Verification and Validation (VnV)
• Post-Market Surveillance (PMS)
Medical Equipment / Software Training
Workshops tailored to your own systems or processes.
Introduction to medical Device regulations
Build-your-own regulatory pathway
Design control for small manufacturers
Assessing and managing suppliers for start-ups and small businesses
Starting risk assessment for your new medical device
Supplier management (ISO 9001; ISO 13485; ISO 17025)
Risk management (ISO 14971; IEC 60812)
Design control (ISO 13485)
Post-market monitoring and review (ISO 9001; ISO 13485)
Software development for medical technology (IEC 62304)
Quality management operations (ISO 9001; ISO 13485; ISO 17025)