At HApi, we're building a comprehensive resource designed to empower medical device and pharmaceutical manufacturers with practical, (nearly) ready-to-use tools documents for risk management and validation. Our goal is to provide a solid foundation and excellent starting points for your internal developments, saving you significant time and effort in fulfilling stringent regulatory requirements. This blog post outlines our current progress and what you can expect from our evolving course series.
Phase 1: Foundational Risk Management According to ISO 14971 (Completed)
Our journey begins with the bedrock of product safety: Risk Management according to ISO 14971:2019. This foundational course is now complete and available. (Note: This course is held in German, as it is mainly about the implementation of risk management (and I work in the DACH region). In general: work instructions are more likely to be written in German. Procedural instructions, templates etc. will be written in English. Therefore, all other content of this roadmap will be in English.) It provides a thorough understanding of how to systematically identify, evaluate, control, and monitor risks associated with medical devices.
Compliance with ISO 14971 is not merely a suggestion; it's a critical requirement explicitly referenced by regulatory bodies worldwide. For instance, the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) emphasize a robust risk management system throughout the entire product lifecycle. Similarly, the FDA's Quality System Regulation (21 CFR Part 820), specifically 21 CFR 820.30(g) on design validation, implicitly requires comprehensive risk management. Our course lays out these principles, ensuring you build a compliant and effective risk management framework from the ground up.
Phase 2: High-Level Risk Analyses for an almost Real-World Medical Device (In Progress)
Building on the ISO 14971 foundation, our second phase is currently in progress. We are developing practical, "high-level" risk analyses, specifically a HAZOP (Hazard and Operability Study) and an FMEA (Failure Mode and Effects Analysis), for a complex medical device we know very well: an in-line arterial blood gas analyzer (alBGA).
The purpose of these analyses is not to be exhaustive, but rather to clearly illustrate the principles and methodologies in a tangible context. By following along with a realistic product example, you'll gain a deeper understanding of how these powerful risk assessment tools are applied. This practical insight is crucial for meeting the expectations of regulatory bodies like the FDA and EU authorities, which demand thorough and documented risk assessment as part of a product's technical documentation and design file.
Phase 3: Process-Specific FMEAs & Beyond (Upcoming – 1-2 Documents per Month)
Following the high-level alBGA analyses, our roadmap will delve into FMEAs for specific manufacturing processes, which will also relate back to the alBGA. Expect to see detailed FMEAs for operations like weighing, bonding, coating, and other critical manufacturing steps.
These process-specific FMEAs are designed to be highly developed starting points for your own internal documentation. While every manufacturer's process is unique and will require adaptation, these templates will significantly reduce your development time. They address the requirements for Good Manufacturing Practices (GMP), which are central to both FDA regulations (e.g., 21 CFR Part 820 for medical devices, 21 CFR Parts 210/211 for pharmaceuticals) and EU GMP Guidelines (e.g., EudraLex Volume 4). Robust process FMEAs are vital for ensuring product quality and preventing non-conformities, directly contributing to compliance with standards like ISO 13485:2016 (Medical devices – Quality management systems – Requirements for regulatory purposes).
You can expect these specialized FMEAs, along with subsequent validation documents, to be released regularly – approximately one to two new documents or templates per month.
Future Steps: Process, Test Method, and Computer System Validations (Upcoming)
Our roadmap continues with comprehensive guidance and templates for essential validation activities:
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Process Validation (PV) Plans: Essential for demonstrating that your manufacturing processes consistently produce products meeting predetermined specifications. This directly supports GMP compliance and the quality system requirements of ISO 13485 and the MDR/IVDR.
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Test Method Validations (TMV): Ensuring your analytical and testing methods are fit for their intended purpose, a critical component of quality control.
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Computer System Validations (CSV): Providing structured approaches for validating software, from simple Excel-based analyses to more complex Python-driven systems. This is particularly relevant given guidelines like FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures) and EU GMP Annex 11 (Computerised Systems), which emphasize data integrity and system reliability. Our CSV guidance will equip you to validate systems used throughout your quality management system and manufacturing processes.
Each of these upcoming modules will provide you with strong foundations, allowing you to adapt them efficiently to your unique operational and product specifics.
Our Commitment at HApi
Our mission at HApi is to facilitate your journey through the complex landscape of medical device and pharmaceutical manufacturing. By providing well-structured, practical content derived from deep industry experience, we aim to be your trusted resource, helping you to build robust, compliant, and efficient systems without constantly starting from a blank slate. Stay tuned as we roll out new content, continually expanding this valuable library of ready-to-use resources.