Leading injection moulder and med-tech supplier, Boddingtons, has recouped significant investment in the new Medical Device Single Audit Program (MDSAP) by qualifying for the standard at the first time of asking.
MDSAP is a global regulatory audit approach promoting alignment of Quality Management Systems and Regulatory approaches with the goal of improving medical device safety.
Boddingtons CEO, Andy Tibbs said: ‘I am delighted that all the faith in our quality systems and operations has been repaid in such a positive manner. MDSAP is a great way to celebrate a year of technical achievement and manufacturing progress.’
2019 saw Boddingtons re-enter the Plastics Industry Awards after a three year break – and win the best Industrial Design accolade for the fourth time. ‘Our award-winning Cytosystems work illustrates some of the best manufacturing competences we can offer,’ says Tibbs, ‘and we aim to further develop these through 2020.’
The new year will see Boddingtons design and build an extension of the Class 7 Cleanroom within the £4.6m factory structure opened by Lord Digby Jones in November 2016. This will give Boddingtons ever more scope to process the enquiries that are building as a result of the company’s marketing activities – including exhibiting at Med-Tech Innovation EXPO UK, Medical Technology Ireland, and Medica Compamed, Germany.
‘We enjoyed significant interest and exposure through 2019 as a result of these marketing activities,’ says Tibbs, ‘and we are set to repeat the process again through 2020. Our new manufacturing cleanroom will be ready by February 2020 and will greatly help our workflow for Class 1 and 2 Medical devices.’