Hammarplast Medical manufactures medical devices for the pharmaceutical, diagnostics, surgery, dental and orthopaedic industries. We have a production facility in Bredaryd, Sweden and an assembly facility in Tallinn, Estonia.
We are a full-service supplier of medical device systems and components. The company works primarily with outsourcing, taking full responsibility for the manufacturing of medical device products and systems. Hammarplast Medical also takes active part in the development of new products in cooperation with the customers. The production is carried out in top modern ISO 14644-1 class 8 and class 7 clean-room environments.
We are certified according to ISO 13485:2012, ISO 9001:2008 and MDD (Medical Device Directive 93/42/EEC) since 1998.
Our aim is to be a reliable and long-term partner who strive to achieve the best possible common solutions in collaboration with our customers.
We have different solutions to manufacture your medical device as efficiently as possible. Low cost manual assembly in lower volumes, high speed automatic assembly for higher volumes and fully automatic molding using the latest equipment.
We can provide everything from single assembly and packing operations to a complete medical device with a bill of material of several hundreds of different components delivered as a sterile device.
With our factories in Sweden and in Estonia we have built-up a production line with the latest technic for supplying our customers with the most efficient production and assembling.
We produce high-quality products with several different production techniques.
Automatic and manual assembly takes place in Bredaryd and Tallinn in ISO 14644-1 Class 8 and Class 7 cleanroom. The plastic parts are manufactured, assembled and packaged before they are distributed to our customers.
Hammarplast Medical We can also supply other assembling technique such as UV-gluing and Ultrasonic welding.
Hammarplast Medical is certified according to , ISO 13485:2012, ISO 9001:2008och MDD (Medical Device Directive 93/42/EEC) since 1998.
All production is carried out in clean-room environments, class 7 and 8.
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 perform process validation according to an agreed process validation plan. Process validation is carried out in conjunction with injection moulding, blow moulding, ultrasonic welding, bag sealing and sterilisation.
Validation is broken down into three phases:
These three protocols are used to define tests that will demonstrate that the process consistently and repeatedly produces the desired product according to the predetermined specifications and requirements.
Hammarplast Medical is a family-owned global manufacturer of medical devices. The company consists of two different business areas - customized products and branded products.
Customized products - a partner in development and clean room production of precision polymer medical devices.
Branded products - one of Europe´s largest supplier of disposable plastic products.
Please use the form below to send us your business enquiry or contact us at +46(0)72 143 98 76 or +46 (0)510 618 80 or mail to email@example.com.
For more information about our array of specialised products and services, please visit our website at www.hpm.se.