FDA Compliance

We have more than 20 years experience in handling FDA medical device compliance issues. Our experience includes numerous FDA inspections and 510(k) submissions for a wide range of medical devices. We have had many face to face meetings with FDA staff at both the District Office level and with CDRH in Washington D.C. We know what FDA expects from your quality system and can help you develop a quality system which is simple and practical, yet effective in maintaining your quality objectives and complying with FDA quality system requirements.

Key Benefits

    510(k) Premarket notification submissions and non-filing decisions.
    On-site training in FDA requirements for medical devices.
    Quality system procedure development and documentation.
    Quality system compliance audits.
    How to know the likelihood of an FDA inspection and what to expect.
    How to respond to 483's and Warning Letters.
    Product recalls and medical device reporting requirements.
    FDA requirements for importing and exporting devices.
    Mock FDA inspections and gap analysis.