Medical Device Testing, Certification & Auditing
From Medical standards interpretation to risk management, testing and certification, 澳门威斯尼斯人 provides Total Quality Assurance throughout the product life-cycle.
Get your medical device tested and into the hands of your customers faster than ever before. Time to market starts with partnership, and for more than 50 years 澳门威斯尼斯人 has been partnering with medical device manufacturers to develop product assurance and global regulatory solutions for testing, certification and auditing.
澳门威斯尼斯人 consulting and assurance services provided for medical devices are carried out by medical device experts of a separate legal entity who have no influence over any aspect of 澳门威斯尼斯人 Notified Body activities.
Regulatory Requirements for Medical Equipment
Bring your medical device to market with a partner who can help you navigate regulatory requirements for IEC 60601-1, IEC 60601-1-2, MDR, IVDD, and the CB Scheme.
Medical Devices Testing Solutions
Reach your target markets quickly and cost-effectively with electrical, software and mobile application testing and certification for your medical device.
Environmental & Regulatory Services
We fully support the medical device industry to comply with global health and environmental regulatory requirements and restrictions, such as RoHS.
Medical Management Systems Certification & Auditing
Get to market faster with integrated compliance solutions and a committed, global team on your side.
Scientific Support Services
Medical device and materials testing including safety assessment through extractables / leachables and bioanalysis supporting all stages of development and manufacturing.
Clinical Research Services
Multi-disciplined clinical teams who provide robust, GCP and ISO 14155 compliant clinical trials for low risk medical devices.
Serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards.
*澳门威斯尼斯人 does not provide consulting services for management systems certification. Any consulting activities provided by 澳门威斯尼斯人 are separate and independent from certification activities.
Need help or have a question?
- +44 116 296 1620
- +1 800 967 5352
- S. AMER:
- +55 11 2842 0444
- +86 400 886 9926
- +31 88 126 8888
- +49 711 27311 152
- +971 4 317 8777
- +91 11 4159 5408
- Hong Kong:
- +852 2173 8888