Quality assurance is a critical process for all medical devices. This practice ensures your product functions correctly and reduces the risk to the end user. Failing to carry out the right processes, however, can result in product malfunctions or failure and potentially risk patients’ lives.
We will explore what quality assurance is, what to look for in a contract manufacturing partner, and what the benefits of quality assurance are for your organisation.
What Quality Assurance rules do I need to follow?
Medical devices need to be perfect every time to ensure the safety of patients and meet the demands of the market you wish to work in. For example; if you are looking to sell your product to the European market, you need a CE mark.
Similarly, if you want to sell your product to the US market you will need to ensure you work with a manufacturer that is registered with the FDA. In particular, your manufacturer will need to follow the stipulations set out in the FDA 21 CFR part 820 Quality System Regulations for Medical Devices.
Quality assurance also goes beyond registered marks and includes a wide range of mechanisms including;
- Maintaining quality agreements and plans
- Addressing changes in management and production
- Responding to complaints and feedback in a meaningful way
- Providing you with non-conformance reporting and investigation
- Helping with internal auditing
- Providing results that can be used to analyse and measure business performance
- Giving customers and suppliers the tools to make informed decisions and approve products
This extensive remit makes quality assurance a valuable service for any manufacturer of pharmaceutical, diagnostic, or medical devices.
Who should you trust with Quality Assurance?
With that being said there are several benefits to trusting your quality assurance with an experienced medical device manufacturer such as Europlaz.
In our storied history, we have long supported businesses as they develop medical devices and ensure that we meet these criteria ourselves. We are also completely transparent with our clients and make sure they always know exactly why quality assurance is important.
This valuable service provides you with a constant source of information to help you adapt your procedures and maintain a high level of safety and consistency. A large part of our efficacy of quality assurance is down to the CAPA process.
The CAPA process
CAPA (Corrective and Preventive Actions) is a documented procedure that we use to manage preventive actions. This process ensures that we are able to address issues before they occur and create documented preventive actions (PA) to negate the effects of any potential non-conformities.
The CAPA process is exhaustive and includes requirements for;
- Determining potential non-conformities and their cause
- Evaluating the need for preventive actions
- Planning and implementing identified preventive actions
- Review actions for compliance and effectiveness
This process has helped us establish ourselves as leaders in the medical device manufacturing field and gives our clients the confidence to trust us with their products.
What are the benefits of Quality Assurance?
With this CAPA process, we can reliably plan for non-conformities, address the causes, and create preventative actions. This approach allows you to offer your customers a more reliable product that performs uniformly and meets the standards expected of a medical device. This is a key component of why quality assurance is important to the medical industry as it gives patients the confidence to trust the equipment or product given.
Reviewing actions and dealing with any complaints, feedback, or internal audits is also more effective with good quality assurance. Our quality assurance measures and documents every step of the process and gives you vital information about business and medical performance.
Our team has experience developing a wide range of products from general medical use to highly-specialised use products (such as our neonatal flow sensor for infants). This scope extends and includes the likes of:
- Autoinjector devices
- Intravenous anaesthesia sets
- Sublingual drug delivery devices
- Single-use, sterile medical devices
These products, as well as our experience with bespoke medical device development, show how versatile a quality assurance system is and how it can be adapted to suit your product, market, and needs.
This versatility, transparency and reliability are the biggest benefits of quality assurance but are by no means the only positives. If you’d like to find out more about how we can help you develop medical devices and provide unparalleled quality assurance contact us today and we’ll get started on your next project.
Omnipresent Quality Assurance
With over 40 years of experience, we have extensive knowledge and insight into the medical device design and manufacturing process. Our team is well-versed in ensuring that all quality standards are met, from visual inspections to materials testing and carry out a range of regular QA tests.
These tests, either carried out alone or in concert, are hugely beneficial and allow us to better understand the materials and products we create. We can create bespoke testing and manufacturing operations to suit your needs and can also advise clients on the correct figures and results to expect. Take a look at the videos below for a short snapshot of our processes and see first-hand why quality assurance is so important to medical device manufacturing.
Europlaz – a trusted medical device manufacturing partner
Europlaz has been a central figure in optimising and streamlining all stages of the medical device manufacturing process for decades. Our team has worked with a wide range of clients from multinational corporations to SMEs and has experience with both general usage and highly specialised medical equipment.
By creating our own QMS system, we have been able to learn about our own systems, listen to the pain points of clients and our team, and create a service that delivers high-quality products at an optimised rate.
If you’re interested in finding out more about our services or want to know more about how we adapt solutions to your needs please contact us now. Our commitment to quality has allowed us to expand our operation and gain experience in a wide array of biomedical device design, development, and manufacturing. All with strict adherence to ISO 13485:2016 and FDA 21 CFR part 820 Quality System Regulations.