Need of a Medical Device Regulations Expert

Important results from the project

The purpose was to with the help of an expert with a unique competence of Medical Device Regulations (MRD) set up quality systems, processes, Standard Operating Procedures (SOPs), and practical ways of working early in the company’s life. The goal was to create a quality system, SOPs and processes that the company will work along for a foreseeable future, and to educate our staff so that we can take the company and the first products to the next level.

Expected long term effects

The effect wass expected to be large for the relatively newly started company that AlgoDx is, by developing quality systems and getting work processes in place. The result is as expected, the work has resulted in us now having the right competence to successfully file CE-mark applications for our future MedTech products, , which in the long run will lead to the possibility of earlier interventions and prevention of life-threatening diseases and more efficient intensive care.

Approach and implementation

The project was performed in four work packages. 1. Prestudy and review; the consultant reviewed the company materials and read up on the specific requirements for AlgoDx’s business and specifically for the disease sepsis. 2. Recommendations; the consultant outlined the structure of the quality systems and processes. 3. Implementation; AlgoDx implemented the developed quality system and processes. 4. Audit and follow-up; the consultant performed an audit of the quality system and the ongoing processes. Everything worked out as planned with a successful result.