01
Technical documentation at EU MDR standard
EU MDR requires comprehensive technical documentation for every device — covering design and manufacturing, risk management, clinical evaluation, post-market surveillance, and vigilance reporting. Maintaining this to the required standard, continuously and across a device portfolio, is a substantial operational undertaking.
Skyjed structures all MDR-required documentation categories within the product lifecycle — designed for ongoing maintenance, not one-time filing.
02
Post-market surveillance obligations
MDR and IVDR require that manufacturers conduct ongoing post-market surveillance — collecting and analysing real-world data on device performance and safety, and updating clinical evaluations accordingly. Without structured tooling, PMS processes are manually intensive and inconsistently applied.
Post-market surveillance workflows structured within the product lifecycle — data collection scheduled, findings documented, clinical evaluation updates triggered automatically.
03
Design change management and change control
Every design change to a medical device must go through documented change control — assessing impact on safety, performance, and regulatory status. In fast-moving device development environments, maintaining rigorous change control without slowing innovation is the central tension.
Structured change control workflows that govern design changes without creating bottlenecks — every change documented, assessed, and approved with full attribution.
04
Unique Device Identification and traceability
UDI requirements under MDR and FDA create obligations to maintain structured, traceable device identification data throughout the product lifecycle and supply chain. Managing UDI data accurately — and keeping it current as products change — requires infrastructure most quality teams manage manually.
UDI and device identification data structured within the product registry — always current, always traceable through the supply chain.
05
Notified body audit preparation
MDR audits by notified bodies require that technical documentation, QMS evidence, clinical evaluations, and PMS records are immediately accessible and demonstrably current. Preparing for these audits is a major operational burden for quality teams managing documentation across disconnected systems.
Skyjed collects evidence continuously throughout the product lifecycle — audit-ready at any point, without manual preparation effort.
06
Software as a Medical Device governance
SaMD — including AI-enabled clinical decision support — faces its own lifecycle governance obligations under MDR, the EU AI Act, and FDA's Digital Health Centre of Excellence framework. Managing software lifecycle governance separately from hardware creates documentation gaps and increases compliance risk.
SaMD lifecycle documentation managed within the same governance framework as hardware devices — consistent standards, complete evidence trail.
Product types Skyjed manages
Class I devices
Class IIa/IIb devices
Class III devices
IVD products
Implantable devices
Software as a Medical Device
Wearable medical devices
Diagnostic imaging
Surgical instruments
Point of care devices
Combination products
AI-enabled clinical tools