GxP Engineering Consultancy And Validation Services

Accelerating GxP clients towards their engineering compliance goals. Providing leading expertise in technology systems, which improve productivity, product quality and patient safety. Coming Soon : CPD Approved Medical Device Software Validation Training Course, in line with GAMP 5. Products for Sale : New Document Templates are now Available for Purchase.

GxP Engineering Consultancy And Validation Services

Zener Engineering Services Ltd Logo

GxP Engineering
Consultancy And
Validation Services


Healthcare

Healthcare Provider Services NHS And Private Hospitals

Healthcare Provider Services NHS And Private Hospitals

Healthcare Provider Services
NHS And Private Hospitals

Thumbs Up For Zener Engineering Services Ltd

Cyber Security Training Promotional Video

Cyber Training Registration

Cyber Security Training Promotional Video

Cyber Training Registration

Cyber Security Medical Device Training


This one-day course aims to provide a fundamental understanding of the principles and requirements for Medical Device Cyber Security.

In this course you’ll learn about essential concepts and practices to ensure the security of medical devices. The ultimate learning goal is to equip students with the fundamental knowledge and skills to protect healthcare systems from cyber threats and ensure patient safety.


Download the Course Specification Document for more details below.

Cyber Security Medical Device Training


This one-day course aims to provide a fundamental understanding of the principles and requirements for Medical Device Cyber Security.

In this course you’ll learn about essential concepts and practices to ensure the security of medical devices. The ultimate learning goal is to equip students with the fundamental knowledge and skills to protect healthcare systems from cyber threats and ensure patient safety.


Download the Course Specification Document for more details below.

National Health Service And Private Hospitals

Healthcare Providers, both private and public (NHS), are also catered for, with significant patient risk experience. Whether it’s Regulatory Compliance, Estates and Facilities management, Medical Device maintenance, Decontamination or computer system Data Integrity protection, Zener Engineering Services Ltd (ZES) can provide the engineering solution.


ZES have worked to ensure that NHS Hospital Estates and Facilities,
reach the required standard.


Areas of ZES expertise include:

  • Improvement of ways of working
  • EBME in accordance with MHRA 2021
  • Prince II Projects (large £20m or small)
  • Decontamination Facility Design and Validation
  • Estate and Facility Maintenance & Management
  • Independent Assessment of Patient Pathway & Improvements
  • Medical Device Maintenance Systems (Risk based approaches to reduce cost)
  • Computer System Strategy / Expectations - Information Governance and Security
  • HVAC
  • Washer Disinfectors
  • Quality Water Loops
  • Water Purification Units
  • Steam Generation Plants
  • Autoclaves (Steam Sterilizers)
  • Estate & Facility HTM Compliance (AE)
  • A wide range of Medical Device Servicing and Repairs:
  • Eg Infusion Pumps
  • ECG Monitors etc
Thumbs Up For Healthcare Supported By Zener Engineering Services Ltd

Cyber Security Training Promotional Video

Cyber Training Registration

Cyber Security Medical Device Training


This one-day course aims to provide a fundamental understanding of the principles and requirements for Medical Device Cyber Security.

In this course you’ll learn about essential concepts and practices to ensure the security of medical devices. The ultimate learning goal is to equip students with the fundamental knowledge and skills to protect healthcare systems from cyber threats and ensure patient safety.


Download the Course Specification Document for more details below.

Why Choose ZES?
Zener Engineering Services Ltd Testimonial

"ZES are superb in delivering a great service."


Peter West
Head of Quality Affairs at ECLEVAR

National Health Service And Private Hospitals

Healthcare Providers, both private and public (NHS), are also catered for, with significant patient risk experience. Whether it’s Regulatory Compliance, Estates and Facilities management, Medical Device maintenance, Decontamination or computer system Data Integrity protection, Zener Engineering Services Ltd (ZES) can provide the engineering solution.


ZES have worked to ensure that NHS Hospital Estates and Facilities, reach the required standard.


Areas of ZES expertise include:

  • Improvement of ways of working
  • EBME in accordance with MHRA 2021
  • Prince II Projects (large £20m or small)
  • Decontamination Facility Design and Validation
  • Estate and Facility Maintenance & Management
  • Independent Assessment of Patient Pathway & Improvements
  • Medical Device Maintenance Systems (Risk based approaches to reduce cost)
  • Computer System Strategy / Expectations - Information Governance and Security
  • HVAC
  • Washer Disinfectors
  • Quality Water Loops
  • Water Purification Units
  • Steam Generation Plants
  • Autoclaves (Steam Sterilizers)
  • Estate & Facility HTM Compliance (AE)
  • A wide range of Medical Device Servicing and Repairs:
    • Eg Infusion Pumps
    • ECG Monitors etc
Pharmaceutical Products Validated By Zener Engineering Services Validation Consultants
Validation Consultancy From Zener Engineering Services Ltd
Doctor Administering A Pharma Injection Validated By Zener Engineering Services
Validation Consultancy By An Experienced CSV Consultant To Gamp 5 To Ensure Data Integrity

National Health Service And Private Hospitals

Healthcare providers, both private and public (NHS), are also catered for, with significant patient risk experience. Whether it’s Regulatory Compliance, Estates and Facilities management, Medical Device maintenance, Decontamination or computer system Data Integrity protection, Zener Engineering Services Ltd (ZES) can provide the engineering solution.

ZES have worked to ensure that NHS Hospital Estates and Facilities, reach the required standard.

Areas of ZES expertise include:


  • Improvement of ways of working
  • Prince II Projects (large £20m or small)
  • Decontamination Facility Design and Validation
  • Estate and Facility Maintenance & Management
  • EBME in accordance with MHRA/DB/2006(5)
  • Independent Assessment of Patient Pathway & Improvements
  • Medical Device Maintenance Systems (Risk based approaches to reduce cost)
  • Computer System Strategy / Expectations - Information Governance and Security
  • HVAC
  • Washer Disinfectors
  • Quality Water Loops
  • Water Purification Units
  • Steam Generation Plants
  • Autoclaves (Steam Sterilizers)
  • Estate & Facility HTM Compliance (AE)
  • A wide range of Medical Device Servicing & Repairs:
  • Eg Infusion Pumps
  • ECG Monitors etc

Pharmaceutical Products Validated By Zener Engineering Services Validation Consultants
Validation Consultancy From Zener Engineering Services Ltd
Doctor Administering A Pharma Injection Validated By Zener Engineering Services
Validation Consultancy By An Experienced CSV Consultant To Gamp 5 To Ensure Data Integrity
Zener Engineering Services Ltd Testimonial

"ZES are superb in delivering
a great service."


Peter West
Head of Quality Affairs at ECLEVAR

Thumbs Up For Healthcare Supported By Zener Engineering Services Ltd

Authorising Engineers - Healthcare Engineering Compliance


The ZES Authorising Engineer (AE) services provide expert guidance and support in compliance with the relevant standards, regulations, and best practices for safety-critical systems. With extensive industry knowledge, ZES can assist in the design, management, and auditing of systems such as electrical, mechanical, ventilation, decontamination and water hygiene.

ZES AEs will ensure that Client organisations meet statutory requirements while promoting the highest levels of operational safety and efficiency. Whether it’s risk assessments, auditing, or certification, ZES can help safeguard Client infrastructure and maintain compliance with confidence.

All activities are supported by the highest levels of documentation.

ZES can act on behalf of a trust on a project, to ensure the supplier meets the required standard and delivers on their promises.

Contact ZES for all your engineering compliance needs.

Validation Consultancy And Validation Services Provided By A Validation Consultant
Call ZES The Compliance Experts
Zener Engineering Services Ltd Testimonial

"ZES are superb in delivering a great service."


Peter West
Head of Quality Affairs at ECLEVAR

Authorising Engineers - Healthcare Engineering Compliance


The ZES Authorising Engineer (AE) services provide expert guidance and support in compliance with the relevant standards, regulations, and best practices for safety-critical systems. With extensive industry knowledge, ZES can assist in the design, management, and auditing of systems such as electrical, mechanical, ventilation, decontamination and water hygiene.

ZES AEs will ensure that Client organisations meet statutory requirements while promoting the highest levels of operational safety and efficiency. Whether it’s risk assessments, auditing, or certification, ZES can help safeguard Client infrastructure and maintain compliance with confidence.

All activities are supported by the highest levels of documentation.

ZES can act on behalf of a trust on a project, to ensure the supplier meets the required standard and delivers on their promises.

Contact ZES for all your engineering compliance needs.

Validation Consultancy And Validation Services Provided By A Validation Consultant
Call ZES The Compliance Experts
Thumbs Up For Healthcare Supported By Zener Engineering Services Ltd

Authorising Engineers -

Healthcare Engineering Compliance


The ZES Authorising Engineer (AE) services provide expert guidance and support in compliance with the relevant standards, regulations, and best practices for safety-critical systems. With extensive industry knowledge, ZES can assist in the design, management, and auditing of systems such as electrical, mechanical, ventilation, decontamination and water hygiene.

ZES AEs will ensure that Client organisations meet statutory requirements while promoting the highest levels of operational safety and efficiency. Whether it’s risk assessments, auditing, or certification, ZES can help safeguard Client infrastructure and maintain compliance with confidence.

All activities are supported by the highest levels of documentation.

ZES can act on behalf of a trust on a project, to ensure the supplier meets the required standard and delivers on their promises.

Contact ZES for all your engineering compliance needs.

Validation Consultancy And Validation Services Provided By A Validation Consultant
Call ZES The Compliance Experts
NHS Logo

Don’t just take our word for it...

NHS EBME Department Review:
Improvements Implemented


"I am writing to provide an excellent professional reference for Zener Engineering Services, who were brought in to review the EBME department and make suggestions for improvement, with regards to ways of working, quality systems, personnel structure, staff bandings and management issues.

Due to the excellent quality of the audit report submitted ............ the documented improvements were sufficiently valued to warrant implementation.

Terry Smith
Head of Clinical Engineering
University Hospital Southampton

EBME Case Study

MHRA New Regulations And Update


As part of the ZES Director's role as Chair of the IHEEM Medical Device Technical Platform, he oversaw and advised the MHRA on DB2006 requirement updates and eventual replacement.

The IHEEM team provided significant improvements which led to a step change in medical device maintenance requirements for the NHS.

Update Version 1.3 was issued in 2021 and is available to be downloaded below:

Managing MD 2021

ZES have a wealth of experience to benefit clients and patients.

MHRA New Regulations And Update


As part of the ZES Director's role as Chair of the IHEEM Medical Device Technical Platform, he oversaw and advised the MHRA on DB2006 requirement updates and eventual replacement.

The IHEEM team provided significant improvements which led to a step change in medical device maintenance requirements for the NHS.

Update Version 1.3 was issued in 2021 and is available to be downloaded below:

Managing MD 2021

ZES have a wealth of experience to benefit clients and patients.

Your Dedicated
ZES
Validation Consultant

ZES give the customer
the assurance and peace of mind
of a single point of contact,
with full accountability.

A dedicated ZES Validation
Consultant is ready to help you
with your requirements.

Contact Options

Your Dedicated ZES
Validation Consultant

ZES give the customer the assurance and peace
of mind of a single point of contact,
with full accountability.

A dedicated ZES Validation Consultant
is ready to help you with your requirements.
Contact Options

Your Dedicated
ZES
Validation Consultant

ZES give the customer the assurance
and peace of mind of a single point of contact,
with full accountability.

A dedicated ZES Validation Consultant
is ready to help you with your requirements.

Contact Options
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