Regulatory Compliance Services
Medical Systems Consult offers a wide range of Regulatory Compliance consulting services together with our associates and business partnerships with certified test laboratories. We have strengths in product safety conformity assessments for electrical medical systems including Electrical Safety, Basic Safety and Essential Performance, EMC, and Wireless Co-Existence certifications required to gain clearance in the United States, Canada, and European markets.
Our consulting services includes safety and risk management compliance, regulatory strategy consulting for Go-To-Market, quality management audits, FDA 510k/PMA/IDE and CE-Marking submission preparation and support. We always customize our services for each client's needs by bringing the right specialists and brightest minds in the specific field of application. You will get the same experts as the larger organizations, at significantly lower costs because at Medical Systems consult we are truly committed to providing you unbeatable value!
We can perform Quality Assessments of an established Quality Management System, or parts thereof, and technical documentation for a specific project/program, per ISO 13485 and/or MDSAP objectives, and consult with you on how to best bridge any gaps identified. Revisions to Standard Operating Procedures, or other process control documents are identified and generated; similar collaborations to address any gaps in project-specific Design History Files/technical documentation.
You can save significant time and energy by factoring in regulatory compliance directly in your product (design input) requirements. With our diverse knowledge in medical device regulations, and having previously assisted with many successful 510(k) and PMA submissions, we can help ensure your regulatory submission project stays on schedule and acquires successful approval. Our team has expert-level knowledge in medical electrical and international safety standards, the complete end-to-end development life-cycle, DHF and DHR audit and quality checklists, and essential performance requirements per international consensus standards (including clause by clause analysis of IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11, 60601-2-x).
We look forward to the opportunity to be your trusted product development and regulatory compliance partner.
- Prepare 510(k)s, IDEs and PMAs, and support submissions preparing responses to requests for additional information and other FDA correspondence
- Bridge any gaps found in design history documentation creating new content as necessary and directing staff on how to maintain the end-to-end traceability of design controls past the submission and approval (post-market)
- Preparation and assessment of Technical Files and Design Dossiers for European Directives (MDD, AIMDD, LVD, EMC) and Canadian Medical Device Requirements (CMDR) and DHFs (US)
- Preparation of EU and/or CMDR Essential Requirement checklists and Risk Analysis per ISO or EN 14971
- Product safety and EMC conformity assessments
- Provide Product Safety Design Support, including: gap analysis/construction evaluation, independent review and generation of product labeling (including markings), and identification of safety critical components
- Preparation of Clinical literature evaluations. Evaluation of Clinical data per MEDDEV 2.7.1 in accordance with the MDD/AIMDD
- Review of product literature/packaging/labeling to MDD, AIMDD, CMDR, FDA, and IEC 60601 series (including general, collateral, and particular standards in series) requirements
- Perform a gap analysis on a product for conformity with IEC 60601-1, 3rd Edition (Edition 3.0 or 3.1)
- IEC 60601-1, 2nd OR 3rd Edition (Edition 3.0 or 3.1) product safety, essential performance and Risk Management File
- IEC 60601-1-2, EMC design support including Test Plan Preparation, Essential Performance Analysis, Risk Management and related Labeling
- Software Verification and Validation Protocols and Reports (IEC 62304, IQ/OQ/PQ, Tool Validations)
- Support Test Agency Submissions, including interface with the Test Agencies and Witness Testing at Test Lab (UL, CSA, TUV, NEMKO, Intertek, METLABS, etc.)
Quality Management System
- Help maintain Company Standards and Regulations
- Set up a complete Quality Management System (policies, procedures, work instructions), aligned with FDA, MDD, and CMDR regulations for Company
- Audit Company to ISO 9000:2000/2015, ISO 13485:2003/2016, FDA QSR 21CFR820, MDD (EU CE Mark) and CMDR or MDSAP
- Usability Engineering Process per IEC 62366:2016 and IEC 60601-1-6
- Software Development Life Cycle (SDLC) processes for medical devices per IEC 62304
- Risk Analysis, Risk Management, and Software Risk Analysis per ISO 14971 and IEC 62304
- Supply medical device regulatory experts to support other fields including Sterilization, Biocompatibility, and Clinical Studies
Contact us today to find out how we can help with your product development and regulatory compliance needs.