Notified - Body & Competent Authority Audits
A Notified Body is a term originating from EU law that centres around CE Marking and quality system audits. It is their responsibility to assess conformity in accordance with the rules of the EU Directives or Regulations, which involves auditing the manufacturer’s quality system and analysing technical documents pertinent to the device classification and its intended use.
Notified Bodies are pivotal to the regulatory process related to medical devices and IVDs. Their job is to assess the product, validating it before granting a UKCA & CE mark, thus allowing it to be sold in the UK & EU.
In order to ensure a successful Annual Notified Body Audit, medical device manufacturers need to make use of available resources. By taking advantage of an EOMI consultancy pre-audit and during the audit, it can provide assurance that the manufacturer has met the necessary objective evidence requirements, leading to most of our clients passing with minimal or no observations.
Internal - Audits
Internal-auditing is an important part of a company’s internal controls. These audits are designed to assess the efficiency of operations, reporting, and compliance with laws. The audits can identify problems and recommend solutions to those problems. Through these internal-audits, companies can thoroughly examine their operations so that any potential issues can be resolved quickly and effectively.
Our consultants at EOMI consultancy are well-trained in lead auditing and can provide support for MDD93/42EEC, ISO 13485: 2016 and MDR 2017/745. They’ll work with you as a team to perform a gap analysis on your Quality system, giving you peace of mind that the transition is done quickly and compliantly.
MDR 2017/745 transition involves altering the QMS, setting up systems for capturing and processing PMS/PMCF data, conducting an examination of Clinical evaluation reports, regulating DHF documentation, keeping the Risk management file current, and maintaining a UDI database.
We can assist you in selecting a certification body and handling the audit process, removing one worry from your to-do list.
Supplier - Audits
The medical device industry needs to create items that are both secure and efficient in diagnosing and treating diseases. Regulatory authorities, standards organisations, as well as patients have ever higher expectations of safety and performance.
ISO 13485 is a global quality management system standard for medical device manufacturers and sellers. To help them meet the requirements, EOMI Consultancy provides supplier management and ISO 13485:2016 audits.
EOMI Consultancy provides ISO 13485 audit services conducted by our certified auditors. Generally, this involves a two-day onsite review of a company with 50 to 300 personnel. Extra criteria, including the 2016 iteration of ISO 14644 (cleanrooms and other controlled atmospheres) or sterilisation measures may also be taken into account.
EOMI Consultancy can save your company time and resources by providing skilled auditors from a variety of backgrounds to do your third-party audits. Our audit services meet any set standards for distributors, raw materials, contract manufacturers, sterilisation or packaging suppliers.
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