Billev Pharma East is proud to announce a significant milestone in our journey of excellence—we have officially obtained the ISO 13485:2016 certification. This achievement marks us as the first Slovenian consultancy company to be awarded this certification, further solidifying our position as a leader in regulatory affairs and quality management services for medical devices.
The ISO 13485:2016 standard is internationally recognized as the benchmark for quality management systems in the medical device industry. Receiving this certification is a testament to our dedication to maintaining the highest level of professionalism, compliance, and expertise in supporting medical device manufacturers.
Our Certified Scope of Services
With ISO 13485:2016 certification, Billev Pharma East is officially recognized for providing a wide range of specialized services, including:
- Establishment and maintenance of quality management systems for medical devices
- Post-market surveillance services
- Development and management of vigilance activities
- Preparation of clinical evaluations
- Acting as a Person Responsible for Regulatory Compliance (PRRC)
- Providing Authorized Representative (AR) services for non-EU medical device manufacturers
These capabilities position us as a trusted partner for medical device companies seeking expert guidance and regulatory support in navigating the complex European market.
A Commitment to Excellence and Future Growth
Achieving ISO 13485:2016 is more than just a certification—it reflects our unwavering commitment to quality, compliance, and continuous improvement. As the first consultancy company in Slovenia to reach this milestone, we take great pride in setting a new industry standard and leading by example.
This achievement also signals an exciting new chapter for Billev Pharma East. We welcome new clients and partnerships, confident that our expertise, now reinforced by the certification, will provide exceptional value to medical device manufacturers worldwide.
For those seeking a knowledgeable, reliable, and certified partner in regulatory affairs and quality management, Billev Pharma East stands ready to support you every step of the way.
For inquiries and collaboration opportunities, feel free to contact us. We look forward to helping you navigate regulatory challenges with confidence and success!
