Product Design + Engineering, Design Control, Regulatory + Quality Management

From idea to launch…

We lead, support, or supplement your product development effort at all stages of the product lifecycle— we integrate seamlessly with your team to help make your products come to life.

Design Control

Design Control is a crucial process that ensures your medical device is designed to meet the needs of its users and is in compliance with relevant regulations. By following formal design control procedures and creating detailed documentation, you can increase your chances of success in regulatory submissions and FDA audits. Let us help you navigate this complex process and ensure your device is safe and effective for its intended use.

Design Controls and Design History File development for Medical Devices and In-Vitro Diagnostics.

  • The Design History File (DHF) contains all Design Controls, including Requirements, Design Inputs, Design Outputs, Risk Management and Usability. We offer DHF creation or remediation services to set your product development on the right path for approval.

  • Every successful medical device starts with well defined marketing and product requirements. User needs are the specific requirements that undergo Design Validation.

  • We perform all the necessary risk management activities to comply with ISO 14971, including Risk Assessment, Hazard Analysis, Failure Mode Effect Analyses (FMEAs), and risk mitigation and testing.

  • We ensure your device undergoes the proper user evaluations to comply with IEC 62366. Formative and summative usability evaluations formally document the interaction and feedback from your device users for FDA review.

  • We will develop a solid design verification strategy that includes testing and analysis. We ensure product undergoes testing considering worst-case conditions and with statistically valid sample sizes.

  • Ensure your device fulfills the User Needs in a simulated use environment with real users.

  • It’s not enough to simply write the code for your device. Software development for medical devices that follows IEC 62304 ensures that your software output will withstand scrutiny from FDA and other regulatory bodies.

  • Our team has extensive experience designing products and developing the documentation to support those products to comply with the appropriate standards which pertain to medical devices. We have a track record of success demonstrating compliance to the following standards:

    • ISO 13485 - Medical devices — Quality management systems

    • ISO 14971 - Medical devices — Application of risk management to medical devices

    • ISO 10993 - Biological evaluation of medical devices

    • ISO 10555 - Intravascular Catheters

    • IEC 60601-1 - Medical electrical equipment

    • ISO 14708 - Implants for surgery — Active implantable medical devices

    • IEC 62366 - Application of usability engineering to medical devices

    • IEC 62304 - Medical device software

    • ISO 11607 - Packaging for terminally sterilized medical devices

    • ISO 11135 - Sterilization of health-care products

    • ISO 15223 - Medical devices — Symbols to be used with medical device labels

    • IEC 61010-1 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use.

    • ISO 80369 - Small Bore Connectors for Liquids and Gases in Healthcare Applications

  • Product design does not end with the device itself. Every medical device requires labeling that complies with the appropriate standards and FDA guidance. Whether durable or disposable labeling, instructions for use, Unique Device Identification (UDI)— we ensure your product labeling is clear, complete, and compliant.

FREQUENTLY ASKED QUESTIONS

    • Design History File (DHF): contains all Design Controls, including Requirements, Design Inputs, Design Outputs, Risk Management and Usability. This compilation of documents describes how the device was designed and developed.

    • Device History Record (DHR): The compilation of records that described what you did to make a particular device in the manufacturing process. This includes information such as the date of manufacture, the quantity manufactured, acceptance records, labeling/UDI information. etc.

    • Device Master Record (DMR): The DMR documents everything you need to know in order to build a device. This includes information such as device specifications/drawings, process specifications, production methods and procedures, quality assurance procedures, etc.

  • The answer is: it depends. Some Class I devices are not subject to formal design and development planning, formal documentation of design inputs or design reviews. A thorough review of the proposed device and its product code will inform the proper development strategy and scope.

  • Yes! We have extensive experience in Design Controls for both medical devices as well as in-vitro diagnostics. Many of the same regulations and core concepts of a Design History File apply to both areas, and we offer the experience and expertise to distinguish the differences between the two.