KB COMPANY sagl

  • Full service partner for Regulatory & Quality Clinical & Safety
  • Medical devices
  • Cosmetics and food supplements

About

Full service partner for Regulatory & Quality Clinical & Safety: medical devices, cosmetics and food supplements

KB company is a consultancy business organization based In Ticino-Switzerland, specialized in Regulatory & Quality - Clinical & Safety for medical devices, cosmetics and food supplements. Our experienced team helps you navigate and address complex regulations and compliance challenges with strategies for successful regulatory and commercialization outcomes. As your partner, we collaborate with you at every step to ensure success starting from the early concept stage of the product development lifecycle.

Diana Koprivec, MD, PhD

Clinical & Safety Consultant for Medical Devices, Medicinals, Food Supplements and Nutrition; Medical and Lifestyle Coach.

Services

Full service partner for Regulatory & Quality - Clinical & Safety: medical devices, cosmetics and food supplements

Regulatory strategy

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

CRO project management

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

Lead Auditor

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

MDR 2017/45

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

Registration activities in EU and ROW

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

Biological Evaluation

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

PMS/PMCF and PSUR e CH representative for medical devices

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

Why work with us

Our Benefits


Expert Team

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices


Quality Products

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices


Exceptional Customer Service

Regulatory strategy, CRO project management, Lead Auditor, MDR 2017/45, Registration activities in EU and ROW , Biological Evaluation, PMS/PMCF and PSUR e CH representative for medical devices

Projects

Our Successful Projects Showcase

Our Team

Meet KB COMPANY SAGL

Dr. Diana Koprivec has a medical degree from the University of Craiova (1992), is a trained endocrinologist (Bucharest, 2000) and holds a PhD degree in Experimental and Clinical Nutrition (Nutrizione Sperimentale e Clinica, Università Statale di Milano, 2006). After 12 years of medical and academic activity in Romania, Italy and Switzerland she joined industry for further 13 years with different roles (safety and clinical) in both pharmaceutical area and medical device quality system. Starting from 2018 she is an independent clinical and safety consultant for medical devices, food supplements and cosmetics, certified coach and trainer.

Testimonials

Our Customers' Stories


We are extremely satisfied with the services provided by KB COMPANY SAGL. Their attention to detail and professionalism have truly surpassed our expectations. We highly recommend their services to anyone looking for top-notch quality.

― Client


KB COMPANY SAGL has been instrumental in helping us achieve our business goals. Their expert team understands our needs and goes above and beyond to deliver exceptional results. We are grateful for their outstanding support.

― Client


Choosing KB COMPANY SAGL was one of the best decisions we made for our project. Their expertise, reliability, and commitment to excellence have made a significant difference. Thank you for your exceptional service!

― Client

Accreditations & Guarantees

Trusted Accreditations and Guarantees for Our Business

At 'a' business, we hold industry-leading accreditations and certifications, ensuring top-quality service. Our guarantees provide peace of mind to our customers, showcasing our commitment to excellence.


ISO 9001 Certification

Our ISO 9001 Certification demonstrates our dedication to maintaining high standards and continuous improvement in all our operations.


BBB Accreditation

We are accredited by the Better Business Bureau, reflecting our commitment to integrity, honesty, and exceptional customer service.


100% Satisfaction Guarantee

With our 100% Satisfaction Guarantee, we ensure that our customers are happy with our products and services, providing reliability and trust.

Contact

Give Us a Call Today!

We are here to assist you with any questions or concerns. Don't hesitate - reach out now!