quality management systems
quality management systems
quality management systems
advice and support on implementing quality management system. Including ISO 13485:2016 compliance
regulatory compliance
quality management systems
quality management systems
advice and support to achieve regulatory compliance including CE marking, UKCA, MDR and UDI
manufacture & testing
quality management systems
EU & UK representation
we can manufacture and or test your medical devices at our dedicated manufacturing facility
EU & UK representation
quality management systems
EU & UK representation
we provide EU authorized representative services from our Irish office and UK responsible person services from our UK office
quality management systems
All medical device manufacturers are required to have a 13485 compliant Quality Management System (QMS). Our experienced team can discuss your requirements and develop a QMS that is
- Tailored to your specific needs
- Compliant to 13485
- Simple to understand and implement
We can also provide ongoing support to:
- Ensure that the QMS is kept up to date with all the latest regulations and other developments
- Assist with notified body audits
- Conduct audits to ensure your company is implementing the QMS correctly
regulatory compliance
The regulatory requirements for medical devices have gone through a period of change in the last few years and these changes are still in the process of being implemented effecting more and more medical devices.
Some of the changes include:
- Implementation of the Medical Device Regulations in Europe
- Requirement to have an EC Rep to sell in Europe, if you do not have a presence in the EU
- Requirement to have a UK responsible person to sell in the UK, if you do not have a presence in the UK
- Implementation of the requirement to have UDI on the product packaging and eventually on the product
- Brexit means that the UK Medical Device Regulations are now subtly different to those in the EU meaning those applying for a UKCA mark will require different documentation than for a CE mark
Many existing medical device manufacturers are struggling to cope with these new regulatory requirements. Our team are here to help and advise on the new requirements. We can also assist with updating existing technical files or compile new technical files for your medical devices.
For companies starting to make medical devices the regulatory requirements can be daunting. Understanding the requirements and having a realistic regulatory strategy early in the product development is essential to get your product to market as soon as possible. Our team can advise you on how best to handle the regulatory requirements and help you prepare necessary documentation.
sub-contract manufacture
Our skilled assembly operatives assemble a range of medical devices for our clients. Devices we have recently manufactured include:
- Simple mechanical devices such as pole clamps
- Hand held electronic monitors used in operating theatres
- Large complex equipment used in clinical trials
We also operate our own clean room allowing us to assemble sterile devices. All manufacturing is carried out under our certified 13485 quality management system.
testing
Our test facility allows us to undertake testing of medical devices including:
- Final testing of product for product release
- Real time aging testing
- Accelerated aging testing
EU authorized representative
Companies without a presence in the EU are now required to have an EU authorized representative based in the EU if they are placing a medical device on the EU market. Through our office in Ireland we can act as the EU authorized representative for your medical devices allowing you to sell your product in the EU.
UK responsible person
An evolving area is the requirement for companies without a presence in the UK to have a UK based responsible person if they are placing medical devices on the UK market. We are now offering this service through our UK office.