PolarSeal Re-Certified to the New ISO13485:2016 and ISO9001:2015 and Compliant to MDD and UK Medical Device Regulations

Posted Tue, 26th June 2018

PolarSeal are proud to announce during our recent Audit this month undertaken by the LRQA that we have now been certified to the new standards; ISO13485:2016 and IS09001:2015. We have also been recertified as compliant with the MDD (medical device directive) 93/42/EEC and UK Medical Device Regulations.

(To view our updated certification, please click: ISO 134845:2016 and ISO9001:2015)

ISO13485:2016 Specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices to consistently meet customer and regulatory requirements.

For more info on ISO13485: https://www.iso.org/standard/59752.html

Organisations can be involved in multiple stages of the life-cycle from design and development, all the way through to distribution and installation of a medical device.

ISO9001:2015 is the international standard that specifies requirements for a quality management system (QMS). Organisations use the standard to demonstrate the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

For more info on ISO9001: https://www.iso.org/standard/62085.html

CE Marking capabilities

This logo is placed on medical devices to show they conform to the requirements in the directives. It shows the device is fit for purpose stated and is that it meets the legislation relating to safety. The product can be freely marketed anywhere in the European Union.

See more: MDD directive – https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ce-mark

PolarSeal have  top level experience in bringing products through the CE marking process. From the very beginning through to end-product.  


PolarSeal Re-certified

Why Quality matters?

We at PolarSeal demonstrate an unbroken commitment to quality accreditation. And it is exactly that, our commitment to quality and attention to detail has been key to us in being able to build long-standing customer confidence and relationships over the past 30 years. Our recertification only reinforces that.

Read more about: https://polarseal.net/solutions/quality/

We believe it is essential to anticipate the demands of our customers and to maintain our ongoing business relationship. Certification to these revised standards not only provides recognition of our Quality Management Systems but also demonstrates our commitment to providing quality products and services to our many partners. Achieving this ISO certification is a great accomplishment by our team.. By achieving ISO13485:2016 and ISO9001:2015 we are holding ourselves accountable to the highest and most current industry standards of excellence

Contact PolarSeal today so that we can help find the right wearable device solution for you!

T: +44 (0)1252 726000
E: enquiries@polarseal.net