News
Biofortuna Ltd Achieve ISO 9001:2008 & ISO 13485:2003
MerseyBIO Incubator company Biofortuna Ltd. has been approved by Lloyds Register of Quality Assurance for ISO 9001:2008 and ISO 13485:2003, for the design and manufacture of their genotyping and phenotyping in-vitro diagnostics products.
The internationally recognised quality-management certifications will now enable the company to sell CE marked products and open up new routes to market throughout Europe. Commenting on the recent certification, Dr Mike Bunce, CEO of Biofortuna said “The rapid progress in quality management is testament to the dedication and skills of our quality team and our consultant David Ashworth of Flintloque Management Systems.”
ISO 9001 places emphasis on quality systems, processes and customer satisfaction and ISO 13485 defines the quality management systems for the manufacturing of medical devices. Dr David Ashworth added “Assisting biotech companies with improvements to their management systems is my passion and working with the people at Biofortuna has been a privilege. The have demonstrated a consistent commitment to overcoming the many challenges involved in the achievements and maintenance of these two International Quality standards. They richly deserve to be on the Lloyds Register of Quality Assured Companies.”
Biofortuna has seen a remarkable end to the year, with the launch of their transplant testing products in July, and more recently the award of Northwest Biomedical Start-Up of the Year, at the 8th Annual Regional BioMedical Awards in November.
For further information email: info@biofortuna.com
For further information go to: www.biofortuna.com
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Biofortuna Ltd Achieve ISO 9001:2008 & ISO 13485:2003
MerseyBIO Incubator company Biofortuna Ltd. has been approved by Lloyds Register of Quality Assurance for ISO 9001:2008 and ISO 13485:2003, for the design and manufacture of their genotyping and phenotyping in-vitro diagnostics products.The internationally recognised quality-management certifications will now enable the company to sell CE marked products and open up new routes to market throughout Europe. Commenting on the recent certification, Dr Mike Bunce, CEO of Biofortuna said “The rapid progress in quality management is testament to the dedication and skills of our quality team and our consultant David Ashworth of Flintloque Management Systems.”
ISO 9001 places emphasis on quality systems, processes and customer satisfaction and ISO 13485 defines the quality management systems for the manufacturing of medical devices. Dr David Ashworth added “Assisting biotech companies with improvements to their management systems is my passion and working with the people at Biofortuna has been a privilege. The have demonstrated a consistent commitment to overcoming the many challenges involved in the achievements and maintenance of these two International Quality standards. They richly deserve to be on the Lloyds Register of Quality Assured Companies.”
Biofortuna has seen a remarkable end to the year, with the launch of their transplant testing products in July, and more recently the award of Northwest Biomedical Start-Up of the Year, at the 8th Annual Regional BioMedical Awards in November.
For further information email: info@biofortuna.com
For further information go to: www.biofortuna.com
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E info@2bio.co.uk | Map & Directions
T +44 (0) 151 795 4100 F +44 (0) 151 795 4101
E info@2bio.co.uk | Map & Directions