“Notified Body” is a European-centric term derived from EU legislation, and as such these third-party organizations focus on CE Marking compliance and quality system audits. The role of a Notified Body is to conduct a conformity assessment under the relevant EU Directives or Regulations. Conformity assessment typically involves an audit of the manufacturer’s quality system and depending on the device classification, an assessment of associated technical documentation

Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market.

A lot of resources are utilized for Annual Notified body Audit’s preparation and if the notified body audit is not faced properly medical device manufacturer can get observation which are time consuming to close. When a Lead Auditor is an Auditee who know what the Notified body Auditor requires as objective evidence most of our clients clear the audit with minor or no observation

In accordance with ISO 13485: 2016 clause 8.2.4 and 21CFR820.22 a Medical Device Manufacturer’s Quality Management System must be audited in accordance with a documented procedure which must be completed impartially by competent personnel.

All our consultants at Sushvin are ISO 13485: 2016 internal Audit trained and can help your organization to be compliant and conduct annual internal audit as per ISO13485: 2016 and 21CFR820.

Internal Audit help an organization with to continuously improve and be audit ready.

Please contact Sushvin for more information.

As per ISO13485 :2016 it is a requirement for the legal manufacturer to conduct supplier audits for any new or potential supplier and annual evaluation.

Sushvin consultancy services supports its clients with 2nd party audits as it takes up valuable company time and resources, here at Sushvin we can offer a service where one of our experienced and highly trained auditors can audit the supplier. Whether it be distributor, raw material, contract manufacturing, sterilization, or packaging provider critical or non-critical supplier we can perform an audit to your specified criteria.

Sushvin consultancy staff are all lead Auditor trained and can help train for Supplier and Internal Audits.

Please contact Sushvin for more information.