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Medical Device Software Validation Consultancy

Zener Engineering Services Ltd • 14 July 2021

Struggling with ISO 13485 Software Validation?

Need Help From a Validation Consultant?

ZES are an organisation that can provide training and practical assistance in Medical Device validation.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The clauses relating to software validation are 4.1.6, 7.5.6 and 7.6

The new MDR regulation now fully applies in EU Member States:

Medical Device Regulation (2017/745)

The new IVDR regulation will come into force during May 2022:

In Vitro Diagnostic Medical Device Regulation (2017/746)

Software Validation is quoted in Section 3.2.5 of both regulations.
Don't leave software validation until the deadline.

IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establish a common framework for medical device software life cycle processes. GAMP 5 ® and IEC 62304 adopt similar approaches to achieve a compliant structure for software to safeguard patients.

If you have concerns about your current state of computer system validation, data integrity and the potential impact it could have on a patient, Zener Engineering Services Ltd can help.

If you require help in meeting these regulatory requirements, contact the experts in software validation. Contact ZES

ZES Office Manager and NHS Nurse Faye Travis

Don’t just take our word for it...

Medical Device FDA 510(k) Clearance:

"Your consultancy was invaluable to us and we appreciate the time and advice you provided. We are currently analysing the information discussed to decide our next course of action...."

Regulatory Affairs Officer

Confidential UK Manufacturer

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