Medical Safety Devices
G&M Compliance offers certification services so you can get your products appropriately tested and certified. By acquiring certification for medical equipment, we provide you with proper assistance and expertise in product testing and certification.
Getting your medical device to market and keeping it there is vitally important in maintaining a successful product. Unfortunately, the maze of regulatory and market-driven requirements may seem impossible to navigate.
Some common issues facing manufacturers are:
- Understanding the differences between the 2nd and 3rd editions of IEC 60601-1
- Spending valuable time and resources learning to write a risk management file
- Understanding and preparing a usability file
- Frustration trying to determine all information required for an FDA 510K submittal package
- Lack of assistance and knowledge in preparing a hazard analysis
With the proper knowledge and expertise, G&M Compliance can help expedite time to market by guiding your organization and medical device toward the required certifications.
G&M Compliance can provide you with experts to assist with:
- Understanding how the 3rd edition requirements of IEC 60601-1 affect the design and required documentation for your device
- Determining which collateral standards are applicable to your medical product, including standards like IEC 60601-1-2, Collateral Standard: Electromagnetic disturbances – Requirements and tests, or IEC 60601-1-11 – Home Healthcare
- The complex and time-consuming process of preparing FDA 510(k) submittals
- PMA & IDE submissions
- Preparation of technical files and design dossiers according to European Directives (MDD, AIMDD, LVD, EMC, IVD)
- Quality Systems, FDA, MDD, and CMDR procedures for your company
- ISO 9000:2000, ISO 13485:2003, QSR, Medical Device Directive (MDD for EU CE Mark) and CMDR Audits and Mock Audits
- Usability Engineering Process per IEC 62366 & IEC 60601-1-6
- Risk analysis, risk management, and software risk analysis
- Act as a compliance engineer on an as-needed basis for any of your product safety needs, including interacting with Test Agencies (UL, CSA, TUV, NEMKO, Intertek, etc.)
- Provide product safety design support, including gap analysis/construction evaluation, review and generation of product labeling and markings, and assistance in selection and review of safety critical components
Whether your company is new, has little experience with medical regulatory compliance, or is an established organization looking to supplement its staff’s knowledge and expertise, G&M Compliance is your full-service compliance solution. Whether you need corrective action—like responding to a letter from the FDA—or preventive action, such as a situational analysis or potential problem analysis for compliance, you need it now and you need it right.
For more information or to request a quote, contact G&M Compliance today.