RAC Certification for Medical Devices: Your Complete Guide to Earning a Regulatory Affairs Certification
If you are working in the medical device industry or planning to break into it, you already know how critical regulatory knowledge is. The RAC (Devices) certification, awarded by the Regulatory Affairs Professionals Society (RAPS), is the gold standard credential that proves you have the expertise to navigate complex global regulatory frameworks. This guide covers […]
Supplier Controls
International standards and global regulations define medical device supplier management as a systematic, risk-based oversight process of external parties that provide materials, components, services, or processes impacting a device’s quality, safety, or regulatory compliance. A fundamental principle across all major jurisdictions is that while a manufacturer may delegate specific tasks to suppliers, the legal responsibility for the safety […]
DATA ANALYSIS TOOLS FOR CONTINUAL IMPROVEMENT IN QMS
One of the core QMS principle enumerated in the ISO13485 is the Plan-Do-Check-Act (PDCA) cycle. The cycle requires that you set indicators for processes, monitor and analyze data. There are three sets of tools you can use for effective data analysis that can drive continual improvement. 1. Basic “7 QC tools” Tool Typical data sets […]
ISO13485 and FDA QMSR – how to satisfy both!
ISO 13485 and FDA’s QMSR are now functionally very close: ISO 13485:2016 is the core of the new 21 CFR Part 820, but QMSR adds a layer of FDA-specific “ISO‑plus” requirements and clarifications. Below is a concise view of (1) where they are the same, (2) where they differ, and (3) how to adjust your […]
Document Retention
The ISO13485 in its clauses 4.2.4 and 4.2.5 lists the requirements for document retention. The retention is at 2 levels: For obsolete documents the standard gives timelines as the highest of the following Record retention follows the longest duration of the three: Records fall into 3 distinct categories with different retention time considerations. Category A: […]
From Policy to Performance: The One Missing Link in your QMS
Three years into my regulatory consulting career, I walked into a mid-sized medical device company for a pre-audit assessment. Their quality policy looked perfect on paper: ambitious, compliant, measurable. But when I asked frontline operators what their personal KPIs were, I got blank stares. The ISO 13485 requires quality objectives “at relevant functions and levels,” […]
Clinical Evaluation of Medical Devices III
Hello and welcome to another brainstorming blog to discuss the clinical evaluation of medical devices! In our previous blog post, we discussed the cycle of clinical evaluation and how to establish one for the continuous evaluation and compliance of specific devices based on risk class. In the current blog, we are going to discuss various […]
Clinical Evaluation of Medical Device – Part II
Welcome back, everyone! We hope your medical devices are performing well and meeting the necessary approval standards. If you require assistance, remember that Alceon Medtech Consulting is here to help. We serve as the regulatory genie for all your medical device requirements. Our previous blog post covered the importance of clinical data generation and its […]
Clinical Evaluation of Medical Device
Since the medical device regulation (EU) 2017/745 by the European Union started getting enforced, manufacturers are struggling with the most important requirement laid out in the regulation, i.e., clinical evaluation of the device. Clinical evaluation in one format or another is required for the devices of all risk classes in regulatory approval of any governing […]