Quality Assurance

Key2Compliance® has extensive experience in helping companies of all sizes in the medical device industry with efficient and time-saving quality work.

We can create processes and management systems that ensure the quality of your business, so that you do not have to worry about when the next audit appears.

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An easy to use and competent cloud solution for quality management provided by Medos made available through Key2Compliance.

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Always ready for inspection!

In the development of medical device products, strategic and effective Quality Assurance (QA) is a key to long-term success. Investing in QA with a high standard from the beginning is an investment for the future that pays off in the long run.

Key2Compliance® offers a wide range of quality services that help your company run development projects in accordance with current regulations in an optimal and resource-efficient way.

Our QA consultants have extensive experience in helping medical device companies with a large number of different services. We can help and support throughout the entire quality work or if you wish, assist in individual parts. 

We can take responsibility for the training of your employees and create functional Quality Management Systems (QMS). We decide the scope of our collaboration together, based on your needs.

Key2Compliance® helps you to:

  • Conduct the quality work by appointing a Quality Manager
  • Build an internal Quality group
  • Support and complement your existing Quality staff
  • Create, implement and update QMS
  • Offer effective software support for your quality work and your QMS
  • Train and update your staff in Quality and regulations
  • Perform GAP analyzes of your QMS (MDR, ISO 13485, ISO9001, ISO 14001, QSR, etc.)
  • Carry out internal audits and mock inspections
  • Perform ost market surveillance
  • Structure the Technical Documentation
  • Review suppliers and other economic actors

Quality Management System (QMS)

It is a regulatory requirement that manufacturers of medical devices in Europe must have a Quality Management System. Although the content of a QMS is described by MDR and IVDR, the exact design is not defined. With the help of ISO 13485 you can get support for design, but the system must always be adapted to the risk class of the products in question and the size of the company.

ISO 13485

ISO 13485:2016 should be used as a support to meet the requirements of a QMS for medical device manufacturers. It is possible to certify against ISO 13485. This is not a requirement, but a good quality receipt to show to authorities, customers and distributors.

Article 10 of the Medical Device Regulation (MDR)/In Vitro Diagnostic Regulation (IVDR)

All medical device manufacturers must comply with Article 10, regardless of risk class. Article 10 contains a number of points that a quality management system must include. All parts are in ISO 13485.

Quality System Regulation (QSR)

The requirements for QMS in the USA are found in the regulations 21CFR820. The regulations are called QSRs and at the moment the USA is in the process of switching from QSRs to ISO 13485. However, there will be special requirements for, for example, change management, recall, etc.

QMS pays off in the long run

  • Increases internal efficiency, you do not have to reinvent the wheel
  • Enables structured work and maintains improvements
  • Creates trust in customers, suppliers and employees, which in turn improves profitability
  • Is a visible proof that the company works in a structured way with quality issues
  • Knowledge is not linked to specific individuals and therefore always maintained within the company
  • Established information flows reduce the risk of extra work and that important tasks are missed
  • Identifies problems quickly and decisions can be made on well-founded information

Collaboration with MEDOS

Key2Compliance® now offer our customers the introduction of a QMS directly in Medos cloud solution for quality management – Focalcube. Focalcube is the IT support for any company in the industry, who want to start a new business with support and structure for their QMS. 

It may also be that you want to update your old paper-based system to create a more active and vibrant quality system. Maybe you want to work more locally, internationally or just more flexibly. The reasons for acquiring a better infrastructure for your company may be several. 

As a company, you always have a lot to gain from switching from a paper-based QMS to a cloud-based digital system. With IT support such as Focalcube, you get full control from wherever you work. Audits and inspections can be carried out remotely. 

Everyone in your staff always have full access to the entire QMS, including all cases and other documentation, and you can thereby maintain the quality required for a modern and efficient medical device company. Focalcube helps you systematize your affairs, suppliers, meetings, audits and your improvement work. You get a tool to involve everyone in the work. Long-term and recurring problems are made visible and you get support in your priorities. 

Happy employees and happy customers! We help you with both installation and maintenance of Focalcube as well as review of all SOPs and routines. 

We implement it throughout the organization at a pace that makes everyone clear about how and why it should be used. From frustrated to calm and confident in less than a couple of weeks.