Hammarplast Medical is certified by RISE according to
ISO 13485 and ISO 9001.
Our classified products are covered by an MDD certificate issued by Intertek Semko AB (NB 0413) until 2024-05-26. We have extended the validity of MDD certificate until 2028-12-31 by agreement and confirmation letter from Intertek Medical Notified Body according to Regulation (EU) 2023/607.
We manufacture in ISO class 8 cleanrooms and operate GMP grade C and FDA-registered facilities.
Through continuous improvement of our processes we ensure to deliver products that comply with regulatory requirements as well as customer requirements and expectations.
All employees are fully responsible for the quality of work done in our organization!
We are a long-term and reliable partner who, in collaboration with our customers, efficiently develops and manufactures user-friendly polymer products as well as services within Life Science that contribute to high patient safety.
With focus on competence and stable processes and through continuous improvements, the effect of the management system is preserved and thereby we ensure that both customer and other relevant requirements are met.