“Quality and safety are business enablers, and a continued priority for us. This goes hand-in-hand with the demands made by the industry.”

Katarzyna Bobrow, EVP Quality & Regulatory Compliance

Stricter regulations result in safer products

At Arjo, we are proud of always putting safety and quality first. To meet the intensified regulatory requirements in the medical device industry, our focus lies on continuously improving our products and processes.

Arjo has established a clear link between business objectives and quality and safety. We prioritize the continued development of safe, effective care with high quality, and work continuously to improve our products and processes.

Our Group-wide Quality & Regulatory Compliance department (QRC) ensures that the organization lives up to its high quality goals.

Our units undergo regular inspections to validate that we are compliant with relevant regulations. Our quality management system is certified in accordance with the internationally recognized ISO 9001:2015 and ISO 13485:2016 standards.

Efficiency on all levels

On our efficiency agenda, we investigate quality and safety improvements throughout the value chain – from design to installation. We also test the effects of the products’ use at several stages during the design process. This takes place internally in our research department and by retailers, but also by our customers after launch.

To increase knowledge and regulatory compliance, we prioritize training and internal communication. We also regard our customers as part of this work. Accordingly, in 2019, we trained even more healthcare professionals in the safe use of our products.

Increased regulations in a global market

To achieve our high demands on quality and safety, we need to comply with all relevant regulations and conduct continuous, comprehensive improvements.

Arjo’s priority lies in ensuring that we comply with all local and regional regulations in the markets we operate in. The three most important regulatory bodies and regulations for us are:

  • EU Medical Device Regulation (MDR)
  • US Food and Drug Administration (FDA)
  • Health Canada Medical Device Regulation

EU Medical Device Regulation (MDR)

Since 2017, all medical device companies operating in the European Union (EU) are required to comply with the new EU MDR regulation, which comes into force in May 2020 after a three-year transition period. Its objective is to protect patients and healthcare professionals through audits and quality requirements for medical devices. MDR means that medical device products must have more comprehensive clinical information.

US Food and Drug Administration (FDA)

The FDA requires that Arjo complies with the quality system regulation for medical devices in the US. Arjo’s production units are regularly inspected by the FDA. Our Medical Device Single Audit Program (MDSAP) certification demonstrates that the requirements are met.

Medical Device Single Audit Program (MDSAP)

MDSAP certification demonstrates compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. It is required in order to sell medical devices in these markets.

150

The number of employees at Arjo who work to assure that our products comply with relevant regulations.

Four success factors in Arjo’s quality and safety work in 2019:

  1. Program for compliance with EU MDR

    We adapted our processes to comply with the EU MDR, underwent an audit in November and passed with positive results. Arjo is now awaiting certification.

  2. MDSAP certified production units

    The production facilities in Suzhou, China, and Poznan, Poland, gained MDSAP certification.

  3. Documentation and processes

    We have improved the documentation for product testing and launch processes.

  4. Optimized customer complaint management

    We developed efficient processes for the management of customer complaints to create more rapid flows and better communication.