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Toolkit for Medical Device Registration by Startups

Medical Devices /MedTech / Diagnostic startups often originate from an Idea to solve a

medical device registration startup toolkit

problem that founders usually have faced themselves from the medical or engineering perspective. However, many founders lack the understanding of a long road ahead for getting the product to market navigating complex regulatory requirements.

Artixio has been on the forefront in helping MedTech innovations and startups by providing guidance right from product development to commercialization using its past experience and wealth of knowledge. Artixio also offers grant to promising early stage innovations through its annual grant program.

Here is a high level summary of how startups can plan their product development and commercialization for new medtech innovations/ideas.

Understand the Regulatory Landscape:

  • Research: Familiarize yourself with the regulatory requirements specific to your target markets (e.g., FDA in the U.S., CE marking in the EU, and CDSCO in India).

  • Engage Experts: Work closely with regulatory consultants or experts to ensure compliance.

Product Classification and Risk Assessment:

  • Classify Your Device: Determine the classification of your medical device (Class I, II, or III) based on its intended use and risk level.

  • Risk Management: Develop a risk management plan (e.g., ISO 14971) to identify and mitigate potential risks associated with your device.

Quality Management System (QMS):

  • Implement QMS: Establish a robust QMS that complies with ISO 13485 standards.

  • Document Control: Maintain accurate records of design history, risk assessments, and changes.

Design Controls and Documentation:

  • Design Inputs and Outputs: Clearly define design inputs (user needs, specifications) and design outputs (product specifications, labeling).

  • Design History File (DHF): Compile all design-related documents in the DHF.