Technical Documentation & ISO 13485 QMS Implementation

Specculo's Technical Documentation & Quality Management service builds the evidence base that EU market access depends on. We develop and remediate the technical documentation required under EU MDR (Annexes II and III) or IVDR, including device description, GSPR checklists, risk management files to ISO 14971, clinical or performance evaluation support, verification and validation evidence, labelling and the post-market surveillance plan. 

In parallel, we design and implement Quality Management Systems aligned to ISO 13485:2016, scaled to your size and stage, and prepare you for notified body audits and MDSAP where relevant. For software and AI-enabled devices we address SaMD lifecycle requirements (IEC 62304), cybersecurity expectations and the documentation overlap created by the AI Act. 

We work hands-on with your team, producing audit-ready files rather than templates you are left to complete alone. Engagements can cover a full technical file build, a gap assessment and remediation of existing documentation, or targeted support on specific sections. We are honest about effort and sequencing, and we catch gaps early, well before a notified body review, where they are far cheaper to fix. 

Deliverables include the completed documentation set, a QMS aligned to ISO 13485, and a readiness assessment ahead of audit. 

The result is robust, defensible documentation that withstands scrutiny and keeps your conformity assessment on schedule.