Compliance
Setting the Standard.
Our Dedication to Quality and Excellence.
At Comeo, our dedication to maintaining the highest standards of quality is not just a commitment; it's a practice we consistently uphold. This means that whether we're working on software for medical devices or any other industry, our workflows, reviews, and quality assurance processes remain consistent and unwavering. We firmly believe that the same level of precision, reliability, and attention to detail that we apply to medical software is equally essential for non-healthcare projects. This holistic approach ensures that every software solution we deliver, regardless of its intended application, meets the same rigorous criteria for excellence and quality.
Our Integrated Management System (IMS) is a testament to our dedication to providing the best service to our customers. Our IMS comprises two management systems:
- Quality Management System (QMS): We've established rigorous quality standards to ensure that our products and services consistently meet or exceed customer expectations.
- Information Security Management System (ISMS): We're devoted to safeguarding your sensitive data and information. Our ISMS is designed to protect your information assets, ensuring confidentiality, integrity, and availability.
Quality standards
Comeo is committed to provide a service that meets our customer’s requirements and exceeds their expectations, that is commercially rewarding to all parties and leads to long term relationships with repeated business from satisfied customers and partners.
We maintain EN ISO 13485 certification and are audited every year by our Notified Body BSI. The formal structure of our Quality Management System is based on the recommendation of the international standard EN ISO 13485. In terms of content and reference requirements for the processes, the “Integrated Management System" follows the following regulations and standards:
- EN ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
- EN ISO 14971 - Medical devices - Application of risk management to medical devices
- EN ISO/IEC 62304 - Medical devices software - Software life-cycle
- EN ISO/IEC 62366-1 - Medical devices – Part 1 - Application of usability engineering to medical devices
- Regulation (EU) 2017/745 on Medical Devices
- Regulation (EU) 2021/2226 on Electronic Instructions for Use
- BE Law 22 December 2020 on Medical device
- CH MedDO 2020 - Swiss Ordinance on Medical Devices
GDPR and Information Security standards
In addition to our ISMS, we understand the importance of data privacy and compliance. We are fully committed to adhering to the General Data Protection Regulation (GDPR), guaranteeing that your personal data is handled with care and respect. Check out our Privacy page for more information.
As part of our ongoing commitment to data security, we are actively working towards achieving ISO/IEC 27001 certification, an internationally recognized standard for information security management systems. Although our ISMS is already in place, we are still in the preparation phase for this certification. This further demonstrates our dedication to upholding the highest level of security and confidentiality in handling your information.
At Comeo, your trust and data security are of paramount importance to us. We are continually improving our processes and systems to provide you with the best possible service while adhering to the highest industry standards
Questions?
Have questions or want to learn more? Contact us today to discuss how we can meet your needs. We're here to assist you every step of the way.
Quality News
January 21, 2021Committed To Quality
Knoware is committed to provide a service that meets our customer’s requirements and exceeds their expectations, that is commercially rewarding to all parties and leads to long term relationships with repeated business from satisfied customers and partners.