Our design process is driven by joint Aproio-client reviews at every phase.

 

Our principal partners have practiced this collaborative approach to Design Control since the mid-80’s, almost a decade before the Food and Drug Administration (FDA) released its design control guidance documents.

 

Aproio: we analyze, design, build & test medtech and other highly regulated products

Some of the design-control standards that we adhere to in our development process are as follows:

 

Quality Management Systems, FDA, EU

  • ISO 13485 – Quality

  • ISO 14971 – Risk Management

  • EN 62304 – Software life-cycle

  • EN 62366 – Usability

  • REACH

  • WEE

  • RoHS

  • CA Prop 65

Medical Safety Design

  • Medical Safety (60601-1,
    60601-1-2, 60601-1-8 etc)

  • ISO 10993 – Biological

  • ISO 11137, 35 – Sterilization

  • EN60529 – Ingress protection

Packaging & Labeling

  • ASTM D4169 – Shipping Containers

  • ASTM D4728 – Random Vibration

  • ASTM D5276 – Drop Test

  • Various other ASTM standards

  • Sterilization

  • ISO 15223 – Symbols

  • ISO 780 – Packaging graphics

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FDA Guidance

Since 1990, the FDA has required that manufacturers who want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:

  • Establishment of an intended use and design inputs

  • A design plan

  • Periodic design reviews throughout the design process

  • Confirmation that the design outputs conform to the design inputs through:

    • Design verification ("did we design the device right?")

    • Design validation ("did we design the right device?")

  • Translation of the design into manufacturable specifications

  • Clear documentation of the entire process in a design history file or DHF.

The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC.

The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.

 

Design Control