KB COMPANY sagl

Regulatory strategy, MDR 2017/45, registration & auditing

Medical devices are subject to strict regulatory and approval processes. Dedicated rules are to be taken into consideration and followed worldwide. Compliance to regulation impacts all stakeholders and is pivotal throughout the entire lifecycle of a medical device. 

PMS, PMCF, PSUR and CER

PMS, PMCF, PSUR and CER are distinct components of the regulatory compliance requirements for the medical device industry. These documents are essential for demonstrating safety, efficacy and quality of medical devices.

CRO project management

Building solid clinical evidence implies strong project management skills in order to ensure that your clinical trials are compliant with all relevant regulations and to the company's objectives.  

CH representative for medical devices

If your company is not located in Switzerland but you want to sell your products on this territory, you are required to appoint an Authorized Representative, also referred to as AR, Swiss Rep or CH Rep, that will serve as a liason between your company and the Swiss Competent Authorities.    

Medical communication and scientific facilitation

Guiding and supporting individuals and groups of people to reach solutions, decisions and outcomes linked to the medical field, including but not limited to medical errors management and scientific expert groups meetings.

Training

Corporate and individual trainings regarding medical aspects of interest and industry requirements.

Medical Coaching, Weightloss Coaching, Job Coaching

Coaching application to medical area, including but not limited to patients enpowerment, weightloss coaching techniques and connection to the professional reintegration after major medical events.

Event Planning

Event planning within scientific, wellness and nutrition areas.