Welcome to HApi (Hans and Patrizia Inschlag)!
We created this platform to tackle the unique challenges of compliance in the medical device and pharmaceutical industries. We know that navigating cleanroom operations, risk management, FMEAs, and validations can be tough and time-consuming.
Our mission is to give you actionable, high-quality digital content as a strong starting point for your projects. Stop "reinventing the wheel" for FMEAs, process validations, or CSVs. Instead, get access to expert-crafted templates and guidance you can adapt, saving you valuable time and resources.
On our site, you'll find resources covering:
* Cleanroom operations
* ISO 14971 Risk Management
* Practical FMEA applications (from high-level to specific processes like weighing, bonding and coating)
* Robust Validation Strategies (PV, TMV, CSV for simple and complex systems)
HApi is here to help you enhance your understanding, kickstart projects, and ensure top-notch documentation. We're committed to being a valuable part of your journey towards easier compliance and greater confidence.
13.07.2025
Roadmap
In der Praxis gibt es deutliche Unterschiede zwischen klassischen FMEA-Methoden und jenen, die explizit den Vorgaben der ISO 14971 folgen. In diesem Beitrag beleuchten wir die Unterschiede und erläutern, wie ISO 14971 das Risikomanagement bei medizinischen Anwendungen präzisiert.
12.06.2025
FMEA
Kurze und einfach Erklärung, warum ein Reinraum überhaupt notwendig ist.
09.06.2025
Clean Room