Medical devices or in vitro diagnostic devices that are placed on the US market, must meet the requirements of their respective Code of Federal Regulations (CFRs).
MARACA International offers a complete list of services to assist the manufacturer in obtaining FDA clearance or approval for his products.
These services for FDA authorization include:
Full management of the manufacturer’s regulatory affairs activities. Small or medium size manufacturers can outsource all or part of their regulatory activities to MARACA International for effective regulatory affairs management.
- General consulting and training on the medical device (MD) and in vitro diagnostic device (IVD) US 21CFR regulations and their impact on your business.
- Hands-on training on specific parts, such as risk management, clinical evidence, clinical study report and the composition of technical documentation using MARACA International templates. This will facilitate your conformity assessment and understanding of the requirements for US product submissions and registrations.
- Review of the technical documentation to identify any deviations from the regulatory requirements.
- Composition of technical documentation and design dossier for third party review.
- Review of your instructions for use and product labels. Advise in the design of labeling, Unique Device Identifier (UDI) and optimization for translation.
- Gap analysis audit of the quality system versus the requirements of the 21CFR 820 Quality System regulation and ISO13485.
- Assistance in third party review selection and in the preparation for a conformity assessment by the third party.
- Advice in the classification of medical devices, IVDs, software, health applications and borderline products.
- Organization of clinical performance evaluation studies, including near-patient and self-testing studies.
- Composition of clinical performance evaluation study plans and reports.
- Assistance in the composition of clinical data, statistical planning, data management and study monitoring.
- Interactions with the FDA.
- Registration of the Manufacturer and listing of the products in the FDA database.
- Assistance with importing your products in the US in compliance with the FDA importation requirements.
- Representing you as US Agent, with location in the USA.
- Expert defense support for regulatory actions by US authorities.
- Management of incidents: Health hazard assessment, incident notification, recall and advisory notices.