Ensure the compliance of your medical devices
AIRMEDICE supports you at every stage in the life cycle of your healthcare products.
Expert in quality and medical regulatory affairs
AIRMEDICE is a consultancy that specialises in the quality and regulation of medical devices.
We offer you customised support to ensure patient safety and the compliance of your healthcare products.
We work with professionals (manufacturers, distributors and subcontractors of all sizes) in the medical devices and Medtech sectors, to offer quality expertise and solutions.
Choosing AIRMEDICE means partnering up with a company recognised for its experience and expertise in the field of medical devices.
By optimising the compliance of your processes, we can help you reduce your costs and get your products into the market faster, while strengthening human relations and collaboration with your team during your project.
Mission & vision
By building a relationship of trust, we help medical industry professionals to:
– Ensure the regulatory compliance of their devices to access markets as quickly as possible with a strategic approach,
– Maintain the performance and quality of their healthcare products with a continuous improvement process,
– Guarantee compliance with current standards and regulations, while anticipating changes thanks to our up-to-date expertise.
Through our experience and sound advice, we aim to improve the quality of life of patients around the world by helping our partners (because our customers are actually partners for us) to develop innovative, high-performance healthcare products.
UP-TO-DATE EXPERTISE
We’re constantly up to date with the latest standards and regulations in the medical industry, guaranteeing relevant expertise.
AVAILABILITY
Proactive support at every stage of the project, with constant availability and considerate assistance.
ADAPTABILITY
Customised advice and support, tailored to the specific needs of each project.
CUSTOMER SATISFACTION
Strong cooperation with transparent communication at every part of the process to create a long-term partnership.
QUALITY INSURANCE
We can help you implement a quality management system that complies with ISO 13485 or 21 CFR Part 820, and that is effective and tailored to your organisation.
- QUALITY MANAGEMENT SYSTEM
- ISO 13485 CERTIFICATION
- PROCESS
- AUDIT
REGULATORY AFFAIRS
We guide you to achieve regulatory compliance throughout the lifecycle of your devices, enabling you to access markets with confidence.
- TECHNICAL DOCUMENTATION
- REGULATION (EU) 2017/745
- CE MARKING
- MDR
RESEARCH & DEVELOPMENT
We support you at every stage in the design of your devices to ensure that they are safe and perform according to the relevant standards and regulations.
- REQUIREMENT SPECIFICATIONS
- PROJECT MANAGEMENT
- DESIGN
- R&D
EU medical devices regulation
2017/745/CE
Quality Management System
ISO 13485
Electromagnetic compatibility
IEC 60601-1-2
Electro-medical devices
IEC 60601-1
Usability
IEC 62366-1
Medical device software
IEC 62304
risk management
ISO 14971
Management systems audit
ISO 19001
Our experience at the service of your medical devices
AIRMEDICE brings you recognised expertise and personalised support to meet your recurring or one-time needs in terms of quality and regulatory affairs.
Clementine Sciascia
Quality and Regulatory Affairs Consultant
CUSTOMER FEEDBACK
Testimonials
For several years, Clémentine has come up to the challenge of designing, manufacturing and selling class I medical devices. Being a quality manager in a very small business requires a high degree of technical versatility and a detailed knowledge of how a company operates, as well as the rigour and methodology needed to carry out this job.
Clémentine took on a one-year assignment as a regulatory affairs consultant as part of a strategic development project, quickly fitting in with the company's organisation and deadlines. Her expertise, combined with her listening and interpersonal skills, enabled us to achieve our objectives in terms of both standards and our quality system. Her involvement was also appreciated in the quality of the transition management at the end of her assignment.
