--- title: Medical Devices canonical: "https://www.qualio.com/solutions/medical-devices" updatedDate: "2026-11-03T14:07:40.000Z" description: "" --- # Medical Devices ## From ISO 13485 to market clearance Design controls, the ISO 14971 risk file and the technical documentation, alongside the procedures that govern them. ## Your products are changing. Compliance needs to keep up. Devices used to change rarely. Now updates ship all year, and every one is a design change. The paperwork fits the old pace, and the releases have stopped waiting for it. ### The risk file trails the release The hazard analysis covers the last version, not this one. ### Training runs on the old revision The procedure changed. The training records did not. ### The technical file falls behind Rebuilt by hand before every submission. ## Qualio compiles the technical file and drafts the reviews Qualio reads the design controls as your engineers change them in Jira, drafts the review and the change control, and routes both to the approvers your procedure names. Once signed, the change goes into the technical documentation, compiled for 510(k), MDR and your market registrations, and Qualio reassesses the records it touched against ISO 13485 and the QMSR, so the documentation is current when the release ships. To ISO 13485 certification. Cleared on a Qualio quality system. Audit findings closed in 90 days. ## Your engineers stay in their tools. Qualio reads the work as it happens. No plugin, no new Jira structure, no migration needed. ### Quality Management Qualio holds the procedures, training, complaints, CAPAs, change controls and supplier records the whole company works in, so every audit finds the approved version of each. ### Regulated Product Lifecycle Qualio links requirements, tests and code to the hazards and design inputs as the work changes, so the technical documentation compiles from design controls your approvers signed, for each market you register in. ### Compliance Frameworks Qualio maps ISO 13485, the QMSR, ISO 14971 and MDR once and assesses every record clause by clause as it changes, so the audit pack exports with the evidence behind each clause. ### Copilot Drafts the change control, the CAPA write-up, the document review and the training quiz from your own records. Every output cites its source and waits for your approval. ## Every change shows what it touches before anyone approves it - Link every procedure, design input, risk, software requirement and test the change affects - Retire the old revision on the effective date, with the retraining assigned to everyone it affects - Give the auditor one change control with the impact, the signatures and the effective date on it ## The reviewer gets the whole technical file, with the approval behind every document - Export the technical file in the structure the reviewer expects, every document at its approved version - Register in a second market from the same records, and Qualio compiles the technical file to that regulation - Start the next version from the last submission, with the approvals that made it ## Qualio keeps the reportability decision with the complaint, dated and signed - Escalate the ticket from Zendesk or Intercom into a complaint, or log one from a distributor or a customer, and see what is already open on the same device - Decide whether it is reportable to FDA or under EU MDR vigilance, and keep the decision, the date and the signature with the complaint - Raise the CAPA from the complaint when the investigation calls for one, with the supplier and the lot linked ## What device companies say ## More content for medical device professionals ## Less time on documentation. More time on the device.