Our certifications

A commitment to quality in service of healthcare professionals and patients

At OptimHal , the quality and safety of our inhalation devices are at the heart of our approach.
We design and manufacture our devices according to strict requirements, in compliance with the international standard ISO 13485:2016 , the global reference for medical devices.

What is ISO 13485:2016 certification?

ISO 13485:2016 standard defines the requirements for quality management systems for companies involved in the design, manufacture and marketing of medical devices .

It is specifically aimed at healthcare sector stakeholders and seeks to ensure that devices consistently meet regulatory requirements , safety standards and clinical expectations .

What this means in concrete terms at OptimHal

ISO 13485:2016 certification covers all our processes, from design to production, and even post-marketing support:

• Mastery of design and development
  Each device is designed according to a rigorous approach, integrating risk analysis, user needs and clinical requirements.
• Full traceability:
  Raw materials, components, manufacturing batches and quality controls are fully traceable.
• Enhanced quality controls:
  Systematic checks are carried out at each key stage of the manufacturing process.
• Risk management and continuous improvement:
  Risks are identified, assessed and controlled, with a continuous improvement approach based on field feedback and monitoring data.
• Regulatory Compliance
  Our processes are aligned with the regulatory requirements applicable to medical devices, including for use in community and hospital settings.

Why this certification is essential for healthcare professionals

For pulmonologists, allergists, general practitioners, pharmacists, hospital teams and buyers , ISO 13485:2016 certification is a guarantee of trust:

✔️ Safety and reliability of devices

✔️ Consistent performance quality

✔️ Compliance with regulatory requirements

✔️ Recognized and audited industrial partner

A lasting commitment to respiratory health

The ISO 13485:2016 certification reflects OptimHal's commitment to providing high-performance, safe and compliant inhalation devices , suitable for medical practices in both urban and hospital settings .

It fits perfectly with our mission:
to support healthcare professionals in the management of respiratory diseases, for the benefit of patients.