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.
Some of the design-control standards that we adhere to in our development process are as follows
Quality Management Systems, FDA, EU
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
- ISO 15223 – Symbols
- ISO 780 – Packaging graphics
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.