All steps in the creation of a medical device are included in medical device manufacturing, such as cardiac mapping system manufacturers, from process design through scaling up to continuing process improvements. Additionally, it covers sterilizing and preparing a gadget for shipping. There are also some less popular yet highly important devices like purge and trap autosampler. This article covers important pieces of the process, pointing out technologies used and quality issues which need to be addressed.
What is a medical device?
Any object designed for medical use is, in general, considered a medical device. These tools aid in patient diagnosis and treatment, enhancing quality of life and assisting patients in overcoming sickness or illness. The use of medical devices may pose risks, thus international organizations and countries have set laws in place to ensure that these items are both safe and effective. The amount of testing that is often necessary before a hardware is authorized to be used increases in proportion to the danger that the item poses. However, it is also true that the potential benefit to the patient increases with risk.
Types of medical devices
In order to be sold for use by patients, medical devices, like pharmaceuticals, must pass a review procedure by the national or international regulatory agencies. Without having any chemical activity on any part of the body, a medical device is used to identify, treat, or prevent a medical illness or condition.
There are three categories of medical equipment:
- Low-risk gadgets are those in class I. Bandages, portable medical equipment, and non-electric wheelchairs are a few examples.
- Devices classified as Class II provide an intermediate risk. Computed tomography (CT) scanners and infusion pumps for intravenous medicine are two examples.
- High-risk devices classified as class III are crucial to maintaining or restoring health. Deep brain stimulators and pacemakers are a couple of examples.
What is medical device manufacturing?
All steps in the creation of a medical device are included in medical device manufacturing, from process design through scaling up to continuing process improvements. Additionally, it covers sterilizing and preparing a gadget for shipping.
Technologies and processes used in manufacturing
Due to their higher startup costs and longer lead times for tooling, traditional manufacturing methods like CNC machining or injection molding are often better suited for producing greater volume items. Prototypes or proof-of-concept designs, as well as special or limited volume products, are better suitable for additive manufacturing.
Also important to take into account are the part geometry and the necessary material qualities. For complicated item shapes, injection molding and additive manufacturing are often preferable, and the material characteristics differ amongst the three groups.
Where are medical devices manufactured?
Most companies used to produce their products in China although the US states like California, Minnesota and Massachusetts are also strong. Pandemic made this part more difficult so for smaller companies and small batch manufacturing it’s easier, cheaper and safer to set up their manufacturing process in countries like Poland which as a whole – comes as a good choice to address needs when time-to-market is crucial.
Best practises in medical device manufacturing
Every medical device manufacturer aims to be quicker and more effective throughout the production process, but they also want to be good corporate citizens. As a result, manufacturing needs ongoing research into sustainable materials, energy-efficient machinery, and waste reduction techniques. Process improvements, technical advancements in machine or equipment components, or the use of safer/more durable materials can all be used as solutions to these problems. The packing process is governed by the same principles.
Eliminating any action, process, or material that does not offer value that a customer would pay for is referred to as “LEAN” manufacturing and is regarded as an industry best practice.
Knowing regulatory standards
Essentially said, regulatory compliance is when a company complies with all applicable local, national, and international rules and regulations. The particular regulatory standards might differ, yet the MDR introduced in 2020 reduced the gap with the FDA regulations.
What you should to know from this article:
- A rule governing the manufacture of medical equipment is known as the medical device regulations (MDR) in the EU.
- A law governing the manufacture of medical equipment used in in vitro diagnostics is known as the IVDR (In Vitro Diagnostic Regulation).
- The present in effect directives 93/42/EWG (MDD) and 90/385/EWG (AAIMDD) must be repealed in order for those rules to take effect. Devices with compliance certifications produced in accordance with the MDD/AAIMDD guidelines may be sold until May 27, 2024
- CE mark – is a producer’s declaration which you need to have to sell medical devices in the EU
- For the US market all regulations and procedures are a domain of the Food & Drug Administration (FDA).
Following quality system practices
ISO standards are crucial for medical device makers because they not only help them produce high-quality medical products but also help them stay in compliance with legal obligations.
This is due to the fact that many ISO standards are either accepted by regulatory organizations like the Food and Drug Administration (FDA) in the US or have been synchronized with laws in other regions of the world, like the European Union.
Therefore, despite the fact that ISO standards do not have legal effect, they are crucial manuals for manufacturers of medical and in vitro diagnostic devices.
A specific standard for medical devices is ISO 13485. It is intended for use by businesses that create, install, maintain, and service medical equipment and associated services. Additionally, it may be utilized by internal and outside parties, including certification organizations, to support their auditing procedures.
Product development and design
Product design and development is regulated by a number of other ISO standards which describe various forms of device components, usage, sterilization, safety effectiveness and security. And these standards are complying with MDR and IVDR requirements as well.
Testing
To demonstrate that innovation can truly survive some forces and the working environment, certification and verification in the actual world are still needed. Make sure you are aware of the acceptance standards for each test. Create a design trace matrix to make sure you haven’t forgotten about your customers’ requirements. This will need to be translated into engineering specifications, which is a difficult undertaking to complete if you lack technical training or expertise.
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