We offer a range of services allowing us to tailor the support we provide to meet our clients needs
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
We can also provide ongoing support to:
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:
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.
Our skilled assembly operatives assemble a range of medical devices for our clients. Devices we have recently manufactured include:
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.
Our test facility allows us to undertake testing of medical devices including:
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.
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.