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Our Service Portfolio

Pragmatic, evidence-first support for MDR and ISO 13485. We help you move from prototype to
market-ready device with clarity, speed, and audit confidence. (Pages in German)

External QMB & Internal Audits

Operate a compliant ISO 13485 system with audit program, findings management, and CAPA coaching.

ISO 13485Audits

Project Management

Lead complex programs with realistic plans tied to regulatory milestones and verification evidence.

ExecutionScale-up

Clinical Evaluation (MDR)

Plan and appraise clinical data aligned with GSPR and PMCF expectations for clean submissions.

CEP/PMCFGSPR

Regulatory Affairs

Operate your RA function end-to-end — submissions, NB interactions, change control, post-market.

MDRNB

Technical Documentation (MDR)

Structure DHF/TF with templates and reviews; identify gaps and build a submission-ready evidence set.

DHF/TFISO 14971

Process Consulting (ISO 13485 / MDR)

Map product and business to lean, scalable processes — reduce overhead without losing control.

Lean QMSScale
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Contact
  • Kerschensteinerstr. 79
    90471 Nürnberg
  • kontakt(at)ipp-nbg.com
Office hours
Monday to Friday
8:00 am - 2:00 pm