Quality, safety and patient comfort

Minitube is committed to manufacturing products of the highest quality. We have a zero-defect policy with substantial resources in Quality Assurance and personnel training.

We comply with the following standards

Minitube medical ISO 13485 En

ISO 13485

Minitube AB has a quality management system certified according to ISO 13485:2016. Our Notified Body is RISE Research Institutes of Sweden.

Download certificate

MDR_flag_black_white_eps-01

Medical Device Regulation EU 2017/745 (”MDR”)

Minitube is MDR-ready, and we comply with the regulations of both MDD and MDR. Our technical documentation includes all risk management documentation, clinical evaluation and post market surveillance.

Read more about MDR

minitube-fda-01

FDA

Minitube is registered as a medical device manufacturer with the U.S. Food and Drug Administration. We have several products registered with the FDA for sale and distribution in the USA, also known as 510(k) market clearance.

See Minitube establishment record and device listings on FDA website

minitube-medical-ce-mark

CE marking

Our products are CE marked and classified in the EU as Class I products (non-sterile).

Minitube-ISO14971

ISO 14971 Risk Management

Our risk management system complies with ISO 14971:2020 Application of risk management to medical devices.

Read more about risk management for Medical Devices

Minitube-läkemedelsverket

Läkemedelsverket/Swedish Medical Products Agency

Request copy of Minitube registration

Minitube-ISO10993

ISO 10993

All our materials have been tested according to the following biocompatibility standards:

In vitro Cytotoxicity (ISO 10993-5)

Irritation and Skin Sensitization (ISO 10993-10)

Systemic Toxicity (ISO 10993-11)

Read more about biological evaluation of Medical Devices

Safe and tested materials

All our materials have been tested according to the following physical standards:

Viral Penetration (ASTM F 1671)

Synthetic blood penetration (ASTM F 1670)

Resistance to puncture (ASTM F 1342)

Tear resistance (ASTM D 1004)

Tensile strength (ASTM D 882)