Empower Your Projects with XACOON
Quality and Regulatory Consultancy
Customer oriented solutions
We are specialized in developing tailored concepts to support, maintain and improve compliance of our customers
in the medical device sector.
Our solution oriented approach is the basis for our consulting services. Our resources have many years of experience
in the medical device and combination product sectors and therefore knows all the needs and critical requirements in
those business areas.
Our core competency is the exact knowledge of the requirements and needs of the various stakeholders including
manufacturers in the different fields (e.g. MDR, MDSAP, ISO 13485 updates).
We are fully focused on the requirements and needs of manufacturers. We work with a broad network of partners.
The xacoon methodology is to encourage collaboration and to create relationships, not transactions.
Our structure is designed to empower your team and outfit them with the tools and personnel they need to succeed.
Talk to us today about how we can support your growth, limit your turnover, and put you on a solid track to success.
ISO 14001 – Environmental Management System
Improve the environmental performance of your organisation and meet policy
commitments and targets
The certification of an environmental management system demonstrates increased awareness of sustainable development and gives environmentally conscious companies a competitive advantage in national and international markets.
ISO 14001 provides a clear management framework for reducing environmental impact. It enables organisations to ensure that they meet legal requirements and gain the trust of stakeholders. The standard provides a systematic approach to planning, implementing and managing an environmental management system.
What is ISO 14001?
ISO 14001 is the most widely recognised international standard for environmental management systems. It is designed to be applicable to all industries, sectors and activities. The standard provides a framework through which an organisation can improve its environmental performance in line with its environmental policy commitments. ISO 14001 specifies the requirements for an organisation to proactively identify the environmental aspects of all its activities, products and services and to understand the associated environmental impacts.
It thus helps organisations to establish an environmental policy and environmental objectives. It also supports them in identifying significant aspects, implementing the necessary controls and setting clear targets for improving environmental performance.
It enables an organisation to manage its commitment to comply with applicable legal regulations and requirements, as well as other obligations to stakeholders, and to regularly review its compliance status. This ensures that the management system is continuously improved and environmental performance is enhanced.
The ISO 14001 standard is designed to be compatible with other recognised management system standards, including ISO 9001.
It is therefore ideal for integration into existing management systems and processes.
Partnership Services
Quality & Regulatory
- Quality Managment Systems (QMS) Development, Gap Analysis and Remediation
- ISO 13485 & ISO 9001
- Remote Quality Managment
- Quality Training
- Supplier Qualification
- Quality Assurance
- Regulatory Compliance - Global
- Device Classification Research
- Pre-Submission Support
- Technical File Submission Preparation
- Correspondence with authorities and notified bodies, as well as with suppliers, importers or distribution partners
Legal Services
- Intellectual Property
- Contract Review
- Contract Development
- Firm Establishment
- Company Merger and/or Sale
Interim Management
xacoon provides you with specialists at all levels. xacoon supports you at the appropriate
level and exactly according to your needs:
- Absence of an employee The unexpected absence of an employee suddenly leaves you short of capacity or essential expertise. We step in.
- Job change – ensuring know-how
Employees build up specific company knowledge during their period of employment. - When they leave, the transfer of this knowledge is at risk.
- We bridge the gap until the new employee starts, thus ensuring the transfer of know-how.