Library
The device file builds itself
The medical device file and design & development file assemble continuously from specification, manufacturing, packaging and labelling records already in the system.
IndustriesMedical Devices
• Medical Devices
The device file assembles itself as the work happens
Design control, production and post-market surveillance on one record. Built for 21 CFR Part 820 as amended by the QMSR, ISO 13485:2016 and EU MDR.
Supported frameworks, not certifications. Regulatory updates included.
Every serial has a history.
- 01Component acceptance
- 02Assembly history
- 03Device release
20 configured controlsFDA 21 CFR Part 820 / QMSR · ISO 13485:2016 · ISO 14971:2019
One controlled record
Why now
Your quality system
is the regulation now.
Since 2 February 2026, Part 820 incorporates ISO 13485:2016 directly. The vocabulary changed, and so did what an inspector can ask to see.
- New names for the device records
The ISO 13485 medical device file and the design and development file replace the older FDA record terms.
- More of the system is inspectable
Management review, internal audit and supplier audit records are now open to inspection.
- ISO 13485 alone is not enough
Section 820.35 still asks for complaint data elements, servicing records and UDI per device or batch.
What is tailored
One record, from design
to post-market.
Where the Medical Devices pack changes how the core behaves.
Production
UDI per device or batch
UDI recorded per device or batch, with GUDID and EUDAMED attribute changes tracked automatically on a 30-day clock.
CAPA
Complaints with their clock
Complaint intake carries the prescribed data elements and reporting clock from the moment it's logged; nonconformities need an effectiveness review before they can close.
Facility
Servicing under control
Servicing records are held to the same controls as production records, not tracked in a separate spreadsheet.
Built for medical devices
Every device lot, with its history attached.
From supplier to service.
These features switch on with the medical devices pack, on the same record as your design, production and quality work.
01 / Inventory · Device history
Trace a device lot back to its components.
Each lot links back to the supplier lots and receipts behind it, and forward to every build and shipment it reached. The tests and approvals on the lot sit alongside, so the device history is one view, not a binder.
- 01Back to the supplier.
Each device lot links to the supplier lots and receipts behind its components.
- 02Forward to the customer.
Every build and shipment the lot reached is on the same view, so the reach of a complaint is already known.
- 03Evidence before release.
Tests, labelling examination and QA approval sit on the lot, so missing evidence shows before final release.
02 / Shop floor · Qualification
IQ, OQ and PQ, with requalification on schedule.
Each production unit keeps its qualification protocols and history. Requalification rules set when it is due, and the unit cannot run production while it is requalifying.
- 01Every stage on file.
DQ, IQ, OQ and PQ keep their protocols, results and approvals on the unit’s record.
- 02Due by rule.
Requalification rules set when the next PQ is due, so it is planned, not found at an audit.
- 03No production while requalifying.
Work orders cannot start on the unit until the report is approved and QA releases it.
03 / QMS · Complaints
Every complaint starts its own clock.
Complaint intake records the data elements the regulation asks for. Evaluation, investigation and the reporting decision each have an owner and a due date, and the score at stake shows what an open complaint costs your readiness.
- 01The right data at intake.
Intake captures the device, the lot, the complainant and the event, the data elements Section 820.35 still asks for.
- 02An owner for each decision.
Evaluation, investigation and the reporting decision each get a named owner and a due date.
- 03Escalated before the deadline.
A reportable event runs on its market’s clock, such as 30 calendar days under Part 803, and escalates before it expires.
04 / Shop floor · Calibration and servicing
Calibration and servicing under the same controls.
Calibration records and schedules cover every instrument and fixture. Overdue equipment is blocked at the step, and servicing is recorded with the same controls as production.
- 01Every instrument on schedule.
Each instrument and fixture keeps its calibration records, the standard used and its next due date.
- 02Overdue means blocked.
A step that needs an overdue instrument cannot start until a passing calibration is recorded.
- 03Servicing under the same controls.
Servicing is signed and audit-trailed like production, not kept in a separate spreadsheet.
Clocks and licences
Every report has a clock.
Every clock has an owner.
The same event carries a different deadline in each market. The system starts the right timer, names an owner and escalates before it expires. The India pack holds the licensing paperwork.
United States
21 CFR Part 803
30calendar days
Death, serious injury or reportable malfunction
5working days
Event requiring remedial action to prevent unreasonable risk
European Union
EU MDR Article 87
2calendar days
Serious public health threat
10calendar days
Death or unanticipated serious deterioration in health
15calendar days
Other serious incidents
India licensing, built in
Held in the shape an audit reads it.
Whether the audit comes from a CDSCO-registered notified body or from CDSCO directly.
- Class A and B
- Licensed by the state authority on Form MD-5. Since October 2025, central risk classification comes first.
- Class C and D
- Licensed centrally on Form MD-9.
- The pack holds
- The Fifth Schedule quality management system, the plant master file and the device master files.
Controls
20 controls.
6 standards.
Every control below runs on the Compliance Engine. The same record carries the evidence across the plant.
Also mapped21 CFR Part 803 / MDR vigilance
20 controls shown for 21 CFR 820 / QMSR
Append-only, hash-chained audit trail capturing old value, new value, author, time and reason
Medical device file assembled continuously from specification, manufacturing, packaging, labelling and servicing information
Design and development file carrying inputs, outputs, reviews, verification, validation and transfer
Design change traceability, so a change reaches the risk file and the affected released records
Risk management file to ISO 14971, linked to the process steps that implement each control measure
Role-based access control, down to the individual field
Segregation of duties enforced in the system, maker is never checker
Re-authenticated approvals capturing the approver, time and meaning on every release
UDI recorded per device or batch, with GUDID and EUDAMED attribute changes tracked on a 30-day clock
Labelling and packaging examination documented before release, per Section 820.45
Device batch and unit records with full material and process genealogy
Complaint intake with prescribed data elements and the reporting clock attached
Vigilance and MDR reporting routed by jurisdiction against the correct deadline
Servicing records held to the same controls as production records
Management review, internal audit and supplier audit records under full access control and retention
Supplier qualification with audit history and re-qualification scheduling
Nonconformity and CAPA with owners, due dates and effectiveness review before closure
Post-market surveillance data flowing into PSUR preparation
Process validation and equipment qualification with IQ, OQ, PQ and calibration history
Training tied to document version, reassigned on every revision
Regulatory change
We watch the rules.
You do not have to.
The Compliance Engine tracks the rules that apply to you, works out what a change touches, updates the system and re-validates before release. You file no change request.
- • applied
ISO 13485:2016 published
The current medical device quality management standard replaced the 2003 edition. The pack maps its clauses to records in the platform.
- • applied
EU MDR becomes applicable
Regulation 2017/745 replaced the Medical Device Directive, adding UDI, post-market surveillance and stricter technical documentation.
- • applied
QMSR merger absorbed on day one
The ISO 13485 medical device file and design & development file replaced the old device-master-record vocabulary in the pack the same month FDA's rule took effect.
- • upcoming
EUDAMED legacy device registration closes
Devices placed on the EU market before 28 May 2026 and still sold must be registered in the UDI and device module.
- • upcoming
Notified body application gate
For Class B and Class A sterile in vitro diagnostics.
- • upcoming
EU MDR legacy certificates expire
For Class III and implantable Class IIb devices.
- • upcoming
EU MDR legacy certificates expire
For Class IIa, non-implantable Class IIb and the remaining Class I categories.
Validation readiness
Controls built in,
not configured on top.
Validation packs
Available on the Dedicated tier, mapped to your workflows. URS, IQ, OQ, PQ, RTM and GAMP 5.
ISO 27001
Certification in progress. Encryption, access control and backups are described on Security & Trust.
Readiness, scored
The Compliance Engine scores inspection readiness continuously, with guidance on each open gap.
Make it your workflow
Have a requirement
to walk through?
Bring the regulation that keeps you up at night. We will show you the control that answers it, on a batch from your plant.