When you do not know where to start
When dealing with medical devices, it is common to have initial doubts about the applicable requirements, the classification of the product and the certification process. The first step is to clarify the key questions:
- Is my product considered a medical device?
- What requirements must medical devices comply with?
- How are medical devices classified?
- What is the AEMPS? The AEMPS is the Spanish Agency for Medicines and Medical Devices.
Requirements for medical devices
Regarding the requirements that medical devices must meet, it is important to determine whether the organization needs to implement and certify a quality management system based on ISO 13485.
- Is ISO 13485 certification mandatory for my organization?
- How long does it take to complete an ISO 13485 audit? The number of audit days is calculated according to the size, complexity and risk level of the organization. Audit duration is normally calculated following the guidelines of the IAF, the International Accreditation Forum.
External audits in ISO 13485
External audits may include customer audits, supplier audits, certification audits and surveillance audits.
A customer audit takes place when an existing or potential customer audits your organization to verify whether you are able to meet, or are already meeting, their requirements.
When an organization audits an existing or potential supplier, this is considered a supplier audit. Supplier audits can be one of the methods used to meet the requirements related to the control of external providers.