Features / Standards
ISO 13485 software
Medical device quality management. A quality system for medical device organizations: controlled design, risk management, complaint handling and regulatory reporting.
Who it’s for
Medical device designers, manufacturers and their suppliers.
Edition notes. ISO 13485:2016 remains current. In the US the FDA’s Quality Management System Regulation (effective 2 February 2026) incorporates it by reference; FDA-specific obligations still apply.
What you still need
The official standard from ISO (iso.org or your national standards body), and — if you want a certificate — an accredited certification body to audit you. Total ISO helps you build, run and evidence the system; it doesn’t grant certification.
What Total ISO gives you for ISO 13485
Each requirement area below maps to a screen in the app. Your “Requirements” page shows what’s in place and what’s still to do. Coverage for ISO 13485: full requirements map with purpose-built records.
4.2.3Documents and the medical device file
Control documents and keep a file for each device type. File them under “Medical device files”.
In the app: Documents
Quality policy and quality objectives
Top management sets a policy and measurable objectives.
In the app: Documents / Objectives
Resources and competence
People are competent for the work that affects product quality.
In the app: Training matrix
Infrastructure, calibration and measuring equipment
Maintain equipment and calibrate measuring equipment.
In the app: Maintenance & calibration
Risk management in product realization
Apply risk management to product realization and keep the records.
In the app: Risks & opportunities
7.3Design and development
Plan, review, verify, validate, transfer and control changes to design.
In the app: Design & development
Purchasing and supplier control
Evaluate and control suppliers of product and services.
In the app: Vendors
Validation of processes (and software)
Validate processes whose output cannot be fully verified, and software used in the system.
In the app: Process validation
8.2.2Complaint handling and reporting to authorities
Handle every complaint and document whether it must be reported to a regulator.
In the app: Customer complaints
8.2.3Advisory notices, recalls and vigilance
Be ready to issue advisory notices and handle recalls and vigilance events.
In the app: Emergency plans
Internal audit
Audit the quality system at planned intervals.
In the app: Internal audits
Management review
Top management reviews the system.
In the app: Management review
Corrective and preventive action
Correct nonconformities and prevent recurrence, with records.
In the app: Corrective actions
Regulatory requirements
List the laws, permits and other requirements that apply and keep them current.
In the app: Compliance register
Working to more than one standard?
Most requirements overlap, so you enter things once. One risk register, one set of documents, one audit programme, one corrective-action process — shared by every standard you choose. Your plan includes one standard; each extra is a simple monthly add-on (see pricing) — $40/month for ISO 13485 when it isn’t your included one. Try them all free during the trial.
Mapping follows ISO 13485 (2016) as publicly described. Clause numbers appear only where we are confident of them. Standards are revised periodically; check which edition your certification body audits against. ISO is a registered mark of the International Organization for Standardization. Total ISO is not affiliated with or endorsed by ISO.