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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
Aproio Design Control process is standards-based and FDA-compliant

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


  • 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


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
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