Orcanos QMS: The Future of Medical Device Quality Management

Compliance, Risk Management & Design Control,  All in One Platform.
‍Developing a medical device is complex. Compliance requirements, risk management, and design control must align seamlessly to avoid delays, reduce costs, and ensure patient safety. Orcanos’ cloud-based Quality Management System (QMS) simplifies the entire process,  helping you stay compliant while accelerating innovation.

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Accelerate your process to achieve
ISO 13485 compliance

Orcanos QMS software provides a centralized platform to control all quality processes. This eliminates the need for a paper-based quality system and enables organizations to comply with strict FDA regulations and established ISO quality standards.

Document Control

Automate your compliance processes and reduce the bottlenecks on document routing and sign-off. Fire training tasks and use Orcanos Change Control to release new revisions.

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Risk Management
ISO 14971

Integrating risk management into your QMS processes streamlines compliance with ISO 14971 and reduces risk throughout the device lifecycle.

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Change Management (ECO)

Automate change management workflow and release a set of documents in a single batch.

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Complaints Handling

Full Complaints Handling system, configure your workflow, leading you from investigation to resolution.

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CAPA Management

Achieve compliance and enhance your quality control processes with Orcanos CAPA management.

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Audit Management

Get better prepared for your next audit or inspection.

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Nonconformance

Orcanos' nonconformance management simplifies the recording and tracking of non-conformance issues, from identification to resolution.
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Training Management

Streamline Your Employee Training with Orcanos' Training Management Software.


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Supplier Qualification

Consolidate all relevant documents, specifications, supplier schedules, scorecards, quality events, and risk assessments into a single, streamlined QMS.

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Get ready for your next audit today!
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What makes Orcanos stand out?

ALM and QMS

Integrate Design Control (ALM) with Quality Management System and regulation to establish a centralized repository.

Document Generator

Effortlessly generate submission-ready documents (in Word or Excel) that conform to your company's templates.

Integrated Risk Management

Integrating risk management into the development process and quality events helps prevent potential hazards and failures while following ISO 14971 guidelines.

21 CFR Part 11 Compliance

Orcanos supports electronic records and electronic signatures in compliance with 21 CFR Part 11/Annex 11.

Dashboards And Analytics

Keep track of projects and the status of quality procedures with detailed reports and charts through our customized dashboards.

Easy Customization

Our platform offers powerful customization tools to tailor your quality forms, e-sign processes, status flows, mandatory rules, and permissions to your specific needs and your company's Standard Operating Procedures.

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FAQ

Questions teams ask before choosing Orcanos

Everything you need to know about our platform, compliance coverage, and getting started.

What is a medical device quality management system?

A medical device QMS is the documented system of processes: document control, CAPA, complaints, audits, training, supplier management, and risk, that proves a device is designed and manufactured safely. Orcanos delivers all of it as one cloud platform instead of a binder of SOPs and spreadsheets.

How does Orcanos QMS ensure ISO 13485 compliance?

Orcanos maps its workflows directly to ISO 13485 requirements: controlled documents, change control, training records, CAPA, internal audits, supplier qualification, and management review all live in one system with full audit trails. Auditors get a single current source of evidence rather than scattered files.

What is 21 CFR Part 820 compliance?

21 CFR Part 820 is the FDA regulation governing quality systems for devices sold in the US, covering design controls, document controls, CAPA, and records. It is now harmonized with ISO 13485 under the QMSR. Orcanos supports these processes in one system aligned to both.

Does Orcanos QMS support 21 CFR Part 11?

Yes. Orcanos supports electronic records and electronic signatures under 21 CFR Part 11 and EU Annex 11, with controlled user authentication, signature meaning captured at the moment of signing, and an immutable audit trail showing who did what, when, and why.

What is CAPA management software used for?

CAPA software manages corrective and preventive actions from issue to closure: root cause investigation, action plans, effectiveness checks, and approvals. In Orcanos, every CAPA links to the complaints, nonconformances, audit findings, and documents that triggered it, so trends surface instead of staying buried.

How does a medical device QMS reduce risk?

By making risk part of daily work rather than a separate file. Orcanos ties ISO 14971 risk items to requirements, design outputs, CAPAs, and complaints, so a field issue or a design change immediately shows which risk controls it affects, before the next review.

Is Orcanos a good medtech QMS solution?

Yes, particularly for teams that need design control and quality management in one system rather than two. Orcanos serves medtech companies from early-stage startups through large manufacturers, and G2 users have recognised it as a High Performer with one of the fastest go-live times in its category. As IceCure's VP R&D put it: “Orcanos provided the optimal solution for documenting and distributing requirements... their attention helped us transition smoothly into the digital world.”

Why not manage medical device quality with spreadsheets?

Because spreadsheets have no audit trail, no enforced approvals, and no reliable version control - the three things auditors ask for first. They also break traceability as the product grows. Orcanos replaces them with a validated system where every record is linked, signed, and instantly retrievable.

What is the best QMS for medtech companies?

The best QMS is one built for medical device regulation rather than adapted from general manufacturing. Look for ISO 13485 and Part 11 alignment, integrated ISO 14971 risk, and design control in the same platform - the combination Orcanos has been purpose-built around since 2005, configured to how your team already works rather than a template you have to conform to.

How long does QMS implementation typically take?

Weeks, not months, for most teams. Orcanos ships with configurable templates and migration tools, and document control alone can go live in under a week. Covaris, for example, went from onboarding to four days of live auditing in a week and a half, with no back room, no binders, and no scrambling for evidence. Full rollout depends on how many processes you migrate, but G2 reviewers rank Orcanos among the fastest systems to go live.

How is Orcanos different from a QMS built for pharma, like MasterControl?

Platforms like MasterControl were built for pharmaceutical documentation first, with device support added later. Quality and engineering typically stay in separate systems by design, and implementations often run 12 to 18 months. Orcanos was purpose-built for medical devices from day one, with Design Control (ALM) native to the same platform as the QMS, and most teams go live in weeks rather than a year or more.