The Company Behind the
LMS for ISO 13485 Compliance
Built by quality professionals who lived the audit findings — and decided to fix them
We are not a general learning management company that added "ISO 13485" to our feature list. We are a team of medical device quality engineers, regulatory affairs professionals, and compliance technology specialists who built the LMS for ISO 13485 compliance that the industry actually needed — from the ground up, with nothing but QMS training requirements in mind.
We Exist to Eliminate ISO 13485 Audit Findings — Permanently
The LMS for ISO 13485 compliance is not just a product category for us — it is our singular purpose. Every year, thousands of medical device manufacturers receive nonconformances from notified bodies citing inadequate training records, missing competency evaluations, or failed SOP retraining documentation. These are preventable failures.
We built this platform because generic LMS tools were creating these findings — not preventing them. Our mission is to make ISO 13485 training compliance so systematic, so automated, and so audit-ready that a notified body audit becomes a demonstration of quality excellence rather than a source of anxiety.
"We started this company after watching a $4 billion device company fail a notified body audit over training record gaps that a better system would have caught automatically. That audit cost them 90 days and a market authorization delay. We built the LMS for ISO 13485 compliance so no company has to experience that again."— Co-Founders, ISO 13485 Compliance Platform
A Decade of Building Better QMS Training
The Founding Observation
Our founders were on-site as quality consultants when a BSI surveillance audit issued three Major nonconformances — all related to ISO 13485 Section 6.2 training record gaps. The company was using a major enterprise LMS. It simply wasn't built for QMS compliance. That day, the product concept was born.
The First ISO 13485-Native LMS
After two years of design with input from 20 medical device quality managers and three notified body consultants, the first version launched with native ISO 13485 Section 6.2 mapping, automated SOP retraining workflows, and a validated system architecture with IQ/OQ/PQ documentation.
Ahead of the EU MDR Transition
As EU MDR 2017/745 was published, we immediately began mapping Article 10(9) personnel qualification requirements and Article 15 Qualified Person for Regulatory Compliance training obligations — giving customers a clear compliance pathway two years before most competitors recognized the challenge.
Full MDSAP Audit Program Support
Added complete MDSAP audit program training matrix support, enabling manufacturers using the program for FDA, Health Canada, TGA, ANVISA, and PMDA simultaneous compliance to manage all training requirements in a single validated platform.
800+ Manufacturers, Zero Acceptable Audit Gaps
Today, our LMS for ISO 13485 compliance is trusted by over 800 medical device manufacturers across 52 countries — processing more than 5 million training completions annually with a 100% notified body audit reaccreditation rate for customers who implement our full QMS training program.
The Principles That Drive Every Decision
🔬 Medical Device Quality First
Every feature, integration, and workflow we build starts with one question: does this satisfy a specific ISO 13485 training management requirement? We do not build features for general corporate training. Every line of code serves QMS compliance.
📋 Documentation Over Claims
In the ISO 13485 world, undocumented quality is no quality at all. We apply the same standard to ourselves — every compliance claim we make about our platform is backed by written mapping documents, validation evidence, and third-party audit reports available for customer review.
⚙️ Automation Prevents Human Error
The most common ISO 13485 training finding is not negligence — it is the manual process gap. Our philosophy is that compliant outcomes must be the automatic result of the system, not the heroic effort of an overworked quality team. Automation is compliance.
🤝 We Share Your Audit Risk
When a customer faces a notified body audit, our compliance team is available to support them — reviewing their training records, identifying any gaps, and helping prepare the training file for presentation. We treat our customers' audits as our own.
🌍 Global Standards, Local Knowledge
ISO 13485 is global, but its implementation varies by notified body, country, and product class. Our team includes specialists from 14 countries with direct experience navigating BSI, TÜV, SGS, Intertek, Dekra, and LRQA audit expectations.
The Capabilities That Make Our LMS for ISO 13485 Compliance Different
Our team combines deep medical device QMS knowledge with proven compliance technology expertise — a combination that generic LMS vendors simply cannot replicate.
ISO 13485 QMS Specialists
Our regulatory team includes former notified body auditors, ISO 13485 lead auditors, and medical device quality directors with direct experience in the most demanding audit environments globally.
Validated Software Engineering
Our engineering team builds to GAMP 5 standards by default. Software design documentation, risk assessments, change control records, and validation protocols are maintained for every system component.
QMS Integration Architecture
Certified integration connectors for 14 leading QMS platforms. Our integration engineers have built validated data transfer protocols that preserve 21 CFR Part 11 electronic record integrity across system boundaries.
ISO 13485 Training Content
Proprietary training content library covering all ISO 13485:2016 clause requirements — developed by medical device quality professionals and reviewed by former notified body auditors. Updated with each standard revision.
Multi-Standard Regulatory Mapping
Expert mapping across ISO 13485, EU MDR, EU IVDR, MDSAP, 21 CFR Part 820, and country-specific medical device regulations — enabling global manufacturers to manage all training obligations centrally.
Information Security & Data Integrity
ISO 27001 certified, SOC 2 Type II audited, and GDPR compliant. Training records are protected with the same data integrity standards that ISO 13485 requires for quality records — encryption, access control, and immutable audit trails.
Built by People Who Have Run ISO 13485 QMS Programs
Every member of our leadership team has held senior quality, regulatory, or compliance technology roles in the medical device industry — bringing the lived perspective of ISO 13485 practitioners to every product decision.
Former VP Quality at a Class III OEM. Was on-site for the BSI audit that inspired this company. 20 years in medical device QMS management across implantables, IVDs, and combination products.
Former BSI Technical Reviewer and TÜV Rheinland notified body auditor for ISO 13485. Authored training requirement guidance used by three national standards bodies. Leads all regulatory mapping and compliance advisory services.
12 years building GAMP 5 validated software systems for regulated industries. Led CSV programs at two top-20 global medical device companies. Specialist in 21 CFR Part 11 electronic record systems and ISO 13485 software validation requirements.
Former Director of Quality Systems at a 3,000-employee ISO 13485-certified manufacturer. Managed multi-site QMS training programs across Europe and Asia. Leads our implementation, audit preparation, and compliance success team.
The Documentation Behind Every Compliance Claim
ISO 13485 teaches us that quality cannot exist without documented evidence. We apply that principle to ourselves — every capability claim about our LMS for ISO 13485 compliance is backed by written evidence available to customers.
- ✓GAMP 5 Category 4 Validated SystemFull IQ, OQ, and PQ documentation provided to all customers. Pre-written validation protocols available for customer execution during onboarding.
- ✓ISO 13485 Section 6.2 Compliance MappingWritten regulatory mapping document showing exactly how each platform feature satisfies specific ISO 13485 requirements. Available pre-purchase under NDA.
- ✓ISO 27001 Information Security CertificationAnnual third-party certification confirming our information security management system. Certificate and summary available upon request.
- ✓SOC 2 Type II Audit ReportAnnual independent audit of security, availability, and confidentiality controls. Full report shared with enterprise customers under NDA during due diligence.
- ✓21 CFR Part 11 Technical AssessmentWritten technical assessment confirming electronic record and e-signature compliance with all 21 CFR Part 11 subpart B and subpart C requirements.
Validated. Certified. Notified Body Approved.
Every credential that ISO 13485-certified manufacturers require before onboarding a quality system software — documented, audited, and ready for your supplier qualification process.
GAMP 5 Cat. 4
Full IQ/OQ/PQ documentation with change control and validated release process.
ISO 27001
Annual third-party certification for information security management systems.
SOC 2 Type II
Independent audit of security, availability, and confidentiality controls.
21 CFR Part 11
Technical assessment confirming electronic record and e-signature compliance.
ISO 13485 Mapped
Written compliance mapping to all ISO 13485:2016 training-related clauses.
GDPR Compliant
Data Processing Agreement, sub-processor register, and adequacy documentation provided.
The Only LMS Built Specifically for ISO 13485 Compliance
Join 800+ medical device manufacturers who have made ISO 13485 training compliance systematic, automated, and audit-ready — with a platform that was designed for this purpose from day one.