Your Trusted EU Authorised Representative
Osseous is your reliable gateway to the European medical device market
About
We are a dynamic and forward-thinking provider of EU Authorised Representative services for medical device manufacturers worldwide. Our team of regulatory experts is dedicated to helping non-EU companies navigate the complex European medical device regulations and gain efficient access to the EU market.
As your trusted partner, we leverage our expertise and cutting-edge knowledge to ensure your medical devices meet all necessary requirements for CE marking and market access in the EU. Our commitment to staying ahead of regulatory changes and our strong focus on client success make us an ideal choice for both established manufacturers and innovative startups.
Osseous is incorporated in the European Union and is operated by C.H.G Cyprus Healthcare Group Ltd. As part of our commitment to excellence, Osseous holds accreditation for ISO13485:2016 for Medical Devices Quality Management Systems, ensuring the highest standards in our services and processes.
As your trusted partner, we leverage our expertise and cutting-edge knowledge to ensure your medical devices meet all necessary requirements for CE marking and market access in the EU. Our commitment to staying ahead of regulatory changes and our strong focus on client success make us an ideal choice for both established manufacturers and innovative startups.
Osseous is incorporated in the European Union and is operated by C.H.G Cyprus Healthcare Group Ltd. As part of our commitment to excellence, Osseous holds accreditation for ISO13485:2016 for Medical Devices Quality Management Systems, ensuring the highest standards in our services and processes.
Managed by an International Operator
C.H.G Cyprus Healthcare Group Ltd is a private Group established in the EU since 2010 with the vision of promoting health and wellbeing of the communities in which we operate. CHG operations fall into 4 distinctive lines of business, namely care delivery, advisory, and operational management.
The Group is an active member of the UN Global Compact since 2014, a founding member of the Cyprus CSR Network, and EU Network for Workplace Wellbeing. Click here to read the latest Communication of Progress report (“COP”).
CHG holds accreditations for:
• ISO9001:2015 Quality Management Systems
• BS EN 15224:2016 Quality Management Systems in Healthcare
• ISO27001:2016 Information Security
• ISO45000:2018 Occupational Health and Safety
• ISO56002:2019 Innovation Management
The Group is an active member of the UN Global Compact since 2014, a founding member of the Cyprus CSR Network, and EU Network for Workplace Wellbeing. Click here to read the latest Communication of Progress report (“COP”).
CHG holds accreditations for:
• ISO9001:2015 Quality Management Systems
• BS EN 15224:2016 Quality Management Systems in Healthcare
• ISO27001:2016 Information Security
• ISO45000:2018 Occupational Health and Safety
• ISO56002:2019 Innovation Management
Osseous comes from the Latin word for bone, "oss," and describes things that are literally made of bone. Just as your skeleton's osseous structure provides a strong foundation for your body, we help organizations strengthen their core structure to excel in what they do.
Advisory Services
Process Design and Quality Management Systems
- Develop and optimize quality management systems tailored to medical device regulations
- Implement efficient processes to enhance productivity and ensure regulatory compliance
- Conduct gap analyses and provide improvement recommendations
- Implement efficient processes to enhance productivity and ensure regulatory compliance
- Conduct gap analyses and provide improvement recommendations
Management
- Operational: Streamline operations, optimize resource allocation, and improve efficiency
- Financial: Provide strategic financial planning, budgeting, and cost optimization strategies
- Financial: Provide strategic financial planning, budgeting, and cost optimization strategies
Information Security
- Develop robust information security policies and procedures
- Conduct risk assessments and implement mitigation strategies
- Assist with GDPR compliance and data protection measures
- Conduct risk assessments and implement mitigation strategies
- Assist with GDPR compliance and data protection measures
Human Resources
- Design effective organizational structures and job descriptions
- Develop talent acquisition and retention strategies
- Implement performance management systems and training programs
- Develop talent acquisition and retention strategies
- Implement performance management systems and training programs
Compliance
- Regulatory: Ensure adherence to relevant EU and international regulations
- Operational: Develop and implement standard operating procedures (SOPs)
- Conduct internal audits and prepare for external regulatory inspections
- Operational: Develop and implement standard operating procedures (SOPs)
- Conduct internal audits and prepare for external regulatory inspections
EU Authorised Representative Services
The European legislation requires non-EU manufacturers to appoint an authorised representative to market medical devices and IVD medical devices in the EU. Osseous provides comprehensive support and representation to non-EU organizations, ensuring compliance with evolving regulatory requirements.
Our EU Authorised Representative services include:
Our EU Authorised Representative services include:
- Acting as a liaison between manufacturers and EU authorities
- Ensuring compliance with MDR and IVDR regulations
- Facilitating product registration and EUDAMED entries
- Assisting with technical documentation and labeling requirements
- Providing ongoing regulatory updates and support
Contact
Contact us for a consultation with one of our professionals
Osseous Ltd
6 Georgiou Davari, Strovolos 2024
Phone: +357 22053554
Email: info@osseous.eu
© All Rights Reserved
6 Georgiou Davari, Strovolos 2024
Phone: +357 22053554
Email: info@osseous.eu
© All Rights Reserved