ISO 9001
ISO 9001 quality management
ISO 9001 is the international standard for quality management systems. ComplyTrain is structured around its clause structure, so your QMS is audit-ready by design.
Medical devices
One system for ISO 13485, the MDR and the evidence behind them
Medical devices live or die by a quality system: ISO 13485, the EU MDR and the FDA’s QMSR all demand a controlled, evidenced way of working before a device reaches a patient. ComplyTrain gives you the QMS, the technical documentation control and the requirements tracking to run it - and to be ready when the notified body arrives.
What makes this hard
The QMS is the product’s licence to exist
No ISO 13485-grade quality system, no CE mark and no market. Design controls, document control and records are not paperwork here - they are the condition of being allowed to sell.
MDR and QMSR raised the bar
The EU MDR and the FDA’s move to the QMSR added clinical evidence, post-market surveillance and traceability obligations that a spreadsheet-and-shared-drive setup cannot carry.
The technical documentation must always be current
Design history, risk management (ISO 14971), CAPA and post-market data have to reconcile on demand - and drift the moment they live in separate tools.
Audits are frequent and unforgiving
Notified-body and FDA audits expect to see the system operating, not assembled the night before. Missing or inconsistent records become findings that hold up your device.
The frameworks this industry is held to
ISO/IEC 27001
ISO 27001 information security management
ISO 27001 is the standard for an information security management system (ISMS). ComplyTrain gives you the framework to build, run and evidence your ISMS - the certificate stays yours to earn.
ISO 31000
ISO 31000 risk management
ISO 31000 is the international guidance for managing risk. ComplyTrain’s risk management is structured around its process, so risk is a living framework across the organisation, not a spreadsheet reviewed once a year.
How ComplyTrain answers it
Quality Management
A quality system structured to the same clause logic ISO 13485 shares with ISO 9001 - design controls, nonconformities and CAPA, management review - as the spine of your compliance.
Document Control
The technical documentation and design history under version control, with sign-off and full revision history - the evidence a notified body opens first.
Requirements Management
MDR, QMSR and standard requirements captured as a traced set, so each obligation is linked to the evidence that meets it rather than assumed.
Risk Management
Product and process risk kept as a living register alongside your ISO 14971 file, connected to the controls and documents that treat it.
Training Management
Competence and training records for the people whose qualifications the standard - and your auditor - will check.
Why compliance matters in medical devices
It is market access, not overhead
An ISO 13485 quality system and MDR/QMSR conformity are the gate to selling a device at all - the regulator decides whether your product reaches patients.
Patient safety is the standard behind the standard
Design controls, risk management and post-market surveillance exist so that a device is safe and effective in the field, and so failures are caught and corrected.
Cybersecurity is now in scope
Connected devices bring information-security obligations too; an ISO 27001-grade approach increasingly rides alongside the medical QMS.
If you need to get there and have no quality function
A standard usually arrives as a contract condition rather than a project anyone planned for, and often at a company with no quality manager. Software is half the answer. Skylen's consultants are the other half, and because they build on ComplyTrain from day one you keep a live system your team owns rather than a binder and a departed consultant.
Gap assessment
A clause-by-clause read of where you stand against the standard your contract cites, turned into a prioritised plan you could act on with us or alone.
What an assessment coversGuided implementation
Our consultants build the system with your team - procedures, document control, the records you need to keep and the review cadence - and prepare you for the certification audit.
How an engagement worksFull-service quality function
We run and maintain the quality system for you, so a small team can reach and hold a standard without hiring a quality manager.
What full-service means