Quality
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.
Clean room Class 7 & 8 and FDA registred 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!
Quality policy
We are a long-term and reliable partner who, in collaboration with our customers,
efficiently develops and manufactures customized 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.
