Standards

The regulation text, where the work happens.

Medica quotes the clause next to the step it governs. Here is the frame it speaks in, and a sample of the clauses you will meet on the way.

FDA 21 CFR 820 / QMSR

Design controls, document controls, DHF, DMR. From 2 February 2026 the QMSR incorporates ISO 13485:2016 by reference.

ISO 13485:2016

The quality management system standard the EU, Canada, Australia and (via QMSR) the US recognise.

ISO 14971:2019

Risk management: hazard identification, risk estimation and control, residual-risk evaluation, production and post-production information.

IEC 62304

Medical device software life-cycle processes, including software safety classification and SOUP.

IEC 62366-1

Usability engineering: use specification, hazard-related use scenarios, formative and summative evaluation.

IEC 60601-1

Basic safety and essential performance of medical electrical equipment, with the collateral and particular standards.

21 CFR Part 11

Electronic records and electronic signatures: audit trails, signature manifestations, signature/record linking.

EU MDR 2017/745

Classification (Annex VIII), technical documentation (Annex II/III), clinical evaluation (Art. 61), conformity assessment (Annex IX–XI).

Clauses you will meet

FDADesign and development planning
Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.
21 CFR 820.30(b)

FDADesign input
The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s).
21 CFR 820.30(c)

FDADesign output
Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.
21 CFR 820.30(d)

FDADesign review
The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file.
21 CFR 820.30(e)

FDADesign verification
Design verification shall confirm that the design output meets the design input requirements. The results, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
21 CFR 820.30(f)

FDADesign validation
Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall include software validation and risk analysis, where appropriate.
21 CFR 820.30(g)

FDADesign changes
Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
21 CFR 820.30(i)

FDADocument controls
Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise.
21 CFR 820.40

FDAAudit trails
Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information.
21 CFR 11.10(e)

FDASignature manifestations
Signed electronic records shall contain information associated with the signing that clearly indicates: the printed name of the signer; the date and time when the signature was executed; and the meaning (such as review, approval, responsibility, or authorship) associated with the signature.
21 CFR 11.50

FDASignature/record linking
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
21 CFR 11.70

FDAElectronic signature components
Electronic signatures that are not based upon biometrics shall employ at least two distinct identification components such as an identification code and password.
21 CFR 11.200(a)

ISODesign and development inputs
Inputs relating to product requirements shall be determined and records maintained. The inputs shall be reviewed for adequacy and approved. Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with each other.
ISO 13485:2016 §7.3.3

ISOControl of design and development changes
The organization shall document procedures to control design and development changes. The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements.
ISO 13485:2016 §7.3.9

ISOIdentification of hazards and hazardous situations
The manufacturer shall compile documentation on known and foreseeable hazards associated with the medical device in both normal and fault conditions.
ISO 14971:2019 §5.4

IECSoftware development plan
The manufacturer shall establish a software development plan for conducting the activities of the software development process appropriate to the scope, magnitude, and software safety classifications of the software system to be developed.
IEC 62304:2006+A1 §5.1.1

IECEstablish user interface evaluation plan
The manufacturer shall establish and maintain a plan for formative and summative evaluation of the user interface.
IEC 62366-1:2015 §5.7

EUClinical evaluation
Confirmation of conformity with relevant general safety and performance requirements under the normal conditions of the intended use of the device shall be based on clinical data providing sufficient clinical evidence.
MDR Art. 61