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Medical Compliance



  1. FDA The food and drug administration regulates the manufacture and marketing of medical devices in the USA. Recommends testing to IEC 60601 2nd/3rd edition series as part of a 510(k). The FDA does not approve 510k notifications. Rather, the agency makes a determination of whether the device is substantially equivalent to devices already on the market.
    • 510(K)s' Premarket notifications
    • PMA - Premarket Approval Applications
    • PMA Supplements - Application to modify a device which is already approved through the PMA process.
  2. Medical Equipment Evaluation
    • Conduct and Prepare Risk Assessment Investigation.
      • Identify your product Hazards.
      • Define the Risks, the Potential Harm, the Severity and Likelihood of injury.
      • Identify product Pinch, Gap and Sear Points
      • Entrapment: 60601-2-38, 60601-2-52, HBSW.
      • Discuss Anthropomorphic Data for Bariatric patient devices.
    • Prepare Risk Management Documentation:
      • Review Installation and Operation instructions.
      • Discuss Intended usage, Reasonable Misuse and Abuse.
      • Usability. Establish a process to provide for the safety of the patient, user and others.
      • Discus meeting "State of the Art".
      • Discuss Client Risk management experience (Market Research, Clinical Trials).
      • Provide client consulting in making Risk Acceptance decisions.
      • Risk Mitigation: Apply management policies, procedures and practices to minimize risks.
      • Develop ISO/IEC 14971 documentation.
    • Product Construction
      • Define degration of product and Review Essential Performance under Single Fault Conditions.
      • Discuss Temperatures, Overflow, Spillage, Fluid leakage, Cleaning, Sterilization, and construction of ME Equipment.
      • Fire Enclosure and Flammability.
      • Oxygen Compatibility.
      • Stability and Mobility.
      • Enclosure rigidity.
      • Noise and Vibration.
    • Components
      • Researching and using High Integrity Components.
      • Component Conditions of Acceptability.
      • NRTL Recognized Components.
      • Split Inspection for Unrecognized components.
      • CB Scheme component licences.
      • Power Supply and Transformer Issues.
    • Insulation Coordination.
      • Means of Protection.
      • Creepage and Clearance.
      • Prepare Insulation Diagram: Drawing showing BOP, BI, SI, RI, DI circuits.
      • Dielectric Testing.
    • Prepare Test plan for achieving conformance to 60601-1 2nd and 3rd Editions.
      • Discuss Medical Equipment Systems, environment and other equipment.
      • Selection of particular tests.
      • Applied Parts and Leakage Currents.
      • Modification of specific tests for Outdoor use.
      • Pass/Fail criteria.
      • Safety Testing: Electrical, Mechanical, Biocompatibility, Cleaning.
      • Ingress Protection: IPX Rating System and Test.
    • Marking and Documentation
      • Ratings Label Information.
      • Graphics and symbols.
      • Safety Signs (color ISO 3864-1).
      • Indicator Lights (IEC 60601-1-8).
      • Document usability.
      • Technical description.
      • Instruction for use.
      • Package markings.
    • Hospital Beds Side Rail Design.
    • Mattress Performance Testing: BFD BX-11, ASTM 1590, CAL 101, CFR1632, CFR1633.
  3. Re-Manufacturing, Retrofit Kits
  4. Agency Management
    • Statement of Work description.
    • Agency Request for Quote and negotiation
    • Invoicing.
    • Agency Submittal Documentation.
      • Technical File.
      • Clinical Data Report and Post Market Clinial Data.
      • Risk Assessment.
      • Insulation Diagram.
      • Test Data.
      • Product descriptive Information.
      • Manuals.
      • Pictures.
      • Essential Requirements Checklist.
    • Documentation Management.
  5. Standards
    • USA
      • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text). Medical electrical equipment— Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD).
      • AIMD 90/385/EEC The active implantable medical devices directive.
      • IVD 95/C172/02 Vitro diagnostic products.
      • NFPA 99 Standard for Health Care Facilities.
      • FDA CFR 21 Parts 800-1299 MEDICAL DEVICES.
      • FDA CFR 21 SUBCHAPTER H - MEDICAL DEVICES.
      • FDA CFR 21 Part 880.5510 Non-AC-powered patient lift.
      • FDA Guidance - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
      • UL1431 Personal Hygiene and Health Care Appliances.
      • UL1069 Hospital Signaling and Nurse Call Equipment.
      • UL1047 Isolated Power Systems Equipment.
      • UL1331 Station Inlets and Outlets.
      • UL863 Time-Indicating and -Recording Appliances.
      • UL60950 Information Technology Equipment – Safety.
      • Flammability
        • Technical Bulletins
        • BFD IX-11 MATTRESS FIRE TEST (Boston Fire Department).
        • 16 CFR 1632 Standard for the Flammability of Mattresses and Matress Pads (FF 4-72, AMENDED).
        • 16 CFR 1633 Standard for the Flammability (Open Flame) of Mattress Sets January 2011.
        • ASTM E1590 - 17 Standard Test Method for Fire Testing of Mattresses.
        • UL1895 UL Standard for Safety Fire Test of Mattresses.
        • NFPA 267, Standard Method of Tests for Five Characteristics of Mattresses and Bedding Assemblies Exposed to Flaming Ignition Source.
        • California Technical Bulletin 26 - Requirements for Record Keeping and Prototype Testing of Mattresses for Compliance with State and Federal Flammability Laws. Questions and Answers about the Amended Mattress Flammability Standard 16 CFR 1632 (FF 4-72).
        • California Technical Bulletin 116 - Requirements, Test Procedure and Apparatus for Testing the Flame Retardance of Upholstered Furniture.
        • California Technical Bulletin 117-2013 - Requirements, Test Procedure and Apparatus for Testing the Smolder Resistance of Materials Used in Upholstered Furniture.
        • California Technical Bulletin 121 - Flammability Test Procedure for Mattresses for Use in High Risk Occupancies.
        • California Technical Bulletin 129 - Flammability Test Procedure for Mattresses for Use in Public Buildings.
        • California Technical Bulletin 133 - Flammability Test Procedure for Seating Furniture for Use in Public Occupancies.
        • California Technical Bulletin 604 - Notice of Suspension of Flammability Test Method for Bedclothing Products.
      • Environmental
    • Canada
      • CAN/CSA-C22.2 NO. 60601-1-6A:11 (R2016) - Amendment 1:2015 to CAN/CSA-C22.2 NO. 60601-1-6:11, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (Adopted amendment 1:2013 to IEC 60601-1-6:2010) | Modification 1:2015 de CAN/CSA-C22.2 NO. 60601-1-6:11.
    • EU
      • MDD - The Medical Devices Directive COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
      • BS EN 60601-1:2006+A12:2014 Medical electrical equipment. General requirements for basic safety and essential performance.
    • International
      • IEC513 Safety Medical Electrical Equipment
      • IEC 601 series to prove that the device itself does constitute an electrical hazard.
      • IEC60601-1 Medical Electrical Equipment
      • IEC60601-1-1 Systems (Incorporated into the 3rd Edition)
      • IEC60601-1-2 EMC (Incorporated into the 3rd Edition).
      • IEC60601-1-3 Radiology
      • IEC60601-1-4 Programmable Electrical Medical Systems - PEMS (Incorporated into the 3rd Edition).
      • IEC60601-1-6 Usability
      • IEC60601-1-8 Alarm Systems
      • IEC60601-1-9 Environment
      • IEC60601-1-10 Closed loop controllers.
      • Draft 60601-1-11 Home health care
      • IEC60601-2-52 Hopsital Beds
      • IEC60417-SN Graphical Symbols
      • IEC60529 IP Code
      • IEC60664-1 Insulation Coordination
      • IEC60825-1 Laser Products
      • IEC TR60878 Graphical symbols
      • IEC60959-1 Information Technology Equipment
      • BS 7177 British Standard Specification for Resistance to Ignition of Mattresses, Divans and Bed Bases.
      • MHLW (Japan)
      • TGA (Australia)

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