Hammarplast Medical is certified by Rise according to
ISO 13485 and
rated products hold EC certificates according to MDD 93/42 / EEC until 240526, our Notified Body is Intertek. Our class I products meet the requirements
according to MDR 2017/745.
Class 7 & 8 och 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!
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.