Design controls are the requirements governing the design and development of medical devices — planning, inputs, outputs, review, verification, validation, transfer, change control and the design history file.
They appear in ISO 13485 clause 7.3 and in FDA regulation, now incorporated through QMSR.
When they start
At the beginning of commercial design and development, not at submission. This is the single most expensive misunderstanding in early-stage device companies.
A startup that designs for two years without design controls and then attempts to reconstruct the record retrospectively creates a document set that reviewers and auditors are experienced at recognising. Contemporaneous records cannot be manufactured later.
The elements
- Design and development planning — stages, reviews, responsibilities, resources
- Design inputs — requirements, including regulatory and the consequences of failure
- Design outputs — must meet inputs and be verifiable
- Design review — at planned stages, with records of problems raised
- Design verification — outputs meet inputs
- Design validation — device meets user needs and intended use, usually with clinical or simulated-use data
- Design transfer — the design becomes a manufacturable specification
- Design changes — reviewed, verified, validated and approved before implementation
The design history file
The DHF is the compiled record demonstrating the design was developed in accordance with the plan and the requirements. It is not a separate document to write at the end; it is the accumulated evidence of having done the work properly.
Practical advice for early-stage companies
A lean quality system at company formation that satisfies design controls is far cheaper than a full retrospective build before submission. Scope it to where you actually are, and expand as you approach commercialisation.