Monthly Archives: April 2020

“It is thrifty to prepare today for the wants of tomorrow.”–Aesop,   Greek author (620 BC – 560 BC)  Validation costs are normally high and would be subject to more time and resources than a project without such requirements. However, there have always been ways to reduce the impact of these costs.  Below are at least three typical causes for having overly raised costs for validation of a system, together with hints on what to do to bring the costs down. Also listed, is a more future-oriented approach to selecting pre-configured standard systems that have all interfacing systems ready-made, all cloud-based, and fail-safe. But let’s start with the classical fails and costly overdoing:  1. Starting…

US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA Legislation. Adapted from FDA Legislation. Copyright 2020, Kvalito Consulting Group.   How to classify a device under US regulation? How to classify a device under US regulation? In the USA, there are 1700 generic groups of devices classified within 16 medical specialties (21 CFR 862-892). The classification is based on a risk approach. Medical devices classified as Class I are considered as having the lower risk, Class II is considered a moderate risk and class III is the higher risk. How are the…

What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment. What is the difference between Design controls and Risk management? Design Controls prove that the Medical Device is safe, effective and meets the indications for use, and help reduce product risks. In parallel, Risk Management intends to identify, evaluate, analyze, assess and mitigate potential product issues. Indeed, there is a correlation between these two notions, however, the perspectives are different.   What are the steps of the Risk Management process? A risk Management file must include: Risk management Plan Risk Analysis…

What is Vigilance? It is a system for the notification and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving Medical Devices. (MEDDEV 2.12-1, rev.8) What steps shall the manufacturer follow to report an incident? Technical documentation needed for Conformity Assessment Before being launched on the EU market, Medical Devices must be approved by a conformity assessment procedure in order to get the CE mark. Conformity Assessment is mainly based on documents, one of these documents is the technical documentation. It is used to demonstrate compliance with regulatory requirements. Access to the US market also requires detailed documentation. Here…

Classification of software as a Medical device under Medical Device Regulation (European Union)  The first step is to determine whether your software is a Medical Device.   How do you determine if the software is a Medical Device?  Figure 1: How to determine if the Software is a Medical Device. Adapted from COCIR Contribution, Decision diagram for the qualification of Software as Medical Device. Copyright 2020, Kvalito Consulting Group.   If your Software is a Medical Device or a part of a Medical Device, it has to be classified.   How to classify a Software as a Medical Device under MDR?  Figure 2: How to classify a software as a Medical Device. Adapted from the Medical Device Regulation of the European Union, Copyright 2020, KVALITO Consulting Group.  Rule 11 refers to software as a Medical Device:    “Software intended to provide information which is…