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

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GxP Engineering
Consultancy And
Validation Services

Medical Devices

Medical Devices Validation Services
FDA MHRA EMA

Medical Devices Validation Services
FDA MHRA EMA

Medical Devices Validation Services FDA MHRA EMA

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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.

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.

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Medical Device Validation Services Provided By ZES

Zener Engineering Services Ltd (ZES) have worked to ensure medical device manufacturing facilities have reached the required standard for their first inspection. Implementing quality systems which comply with current regulatory requirements and GxP is an area of ZES expertise.

Experts in Medical Device software validation, in line with GAMP 5 guidance and IEC 62304.


Download the Medical Device Services leaflet for more details.

Medical Device Validation Services Provided By ZES

Zener Engineering Services Ltd (ZES) have worked to ensure medical device manufacturing facilities have reached the required standard for their first inspection. Implementing quality systems which comply with current regulatory requirements and GxP is an area of ZES expertise.

Experts in Medical Device software validation, in line with GAMP 5 guidance and IEC 62304.


Download the Medical Device Services leaflet for more details.

Medical Device Validation Services Provided By ZES

Zener Engineering Services Ltd (ZES) have worked to ensure medical device manufacturing facilities have reached the required standard for their first inspection. Implementing quality systems which comply with current regulatory requirements and GxP is an area of ZES expertise.

Experts in Medical Device software validation, in line with GAMP 5 guidance and IEC 62304.


Download the Medical Device Services leaflet for more details.

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The Food and Drug Administration (FDA)

The Medicines and Healthcare products Regulatory Agency (MHRA)

The European Medicines Agency (EMA)

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency of the United States' Department of Health and Human Services and are one of the United States federal executive departments. They are responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA issue a Code of Federal Regulations, with which manufacturers supplying the United States must comply. These include:
  • FDA 510k Clearances
  • FDA 21 CFR 820 (Medical Devices)
  • FDA 21 CFR 821 (Traceability)
  • FDA 21 CFR 830 (Unique Indentification)
  • FDA 21 CFR Part 11 (Electronic Systems)
FDA 510k

ZES have worked with former FDA Inspectors to achieve inspection success.
If you need help with an FDA 510k, why not give ZES a call today.

Need Help With FDA Inspections?

The Food and Drug Administration (FDA)

The Medicines and Healthcare products Regulatory Agency (MHRA)

The European Medicines Agency (EMA)

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. One of the United States federal executive departments, they are responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA issue a Code of Federal Regulations, to which manufacturers supplying the United States must comply. These include:

  • FDA 510k Clearances
  • FDA 21 CFR 820 (Medical Devices)
  • FDA 21 CFR 821 (Traceability)
  • FDA 21 CFR 830 (Unique Indentification)
  • FDA 21 CFR Part 11 (Electronic Systems)
FDA 510k

ZES have worked with
former FDA Inspectors to achieve
inspection success.

If you need help with an FDA 510k, why not give ZES a call today.

Need Help With Inspections?

The Food and Drug Administration (FDA)

The Medicines and Healthcare products Regulatory Agency (MHRA)

The European Medicines Agency (EMA)

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency of the United States' Department of Health and Human Services. One of the United States federal executive departments, they are responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, bio-pharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA issue a Code of Federal Regulations, with which manufacturers supplying the United States must comply. These include:
  • FDA 510k Clearances
  • FDA 21 CFR 820 (Medical Devices)
  • FDA 21 CFR 821 (Traceability)
  • FDA 21 CFR 830 (Unique Indentification)
  • FDA 21 CFR Part 11 (Electronic Systems)
FDA 510k

ZES have worked with
former FDA Inspectors to achieve inspection success.

If you need help with an FDA 510k,
why not give ZES a call today.

Need Help With Inspections?

Are You Ready For An Inspection?
Let ZES Help With The Stress!

Zener Engineering Services Ltd (ZES) have worked closely with FDA, MHRA and EMA inspectors to ensure GxP Facilities, IT Infrastructure, Process Equipment and Computer Systems have reached the required standard for their first inspection and inspections beyond.


Implementing quality systems, which comply with current regulatory requirements and cGxP, is an area of ZES expertise.

FDA MHRA Regulatory Inspection Stress

Medicines and Healthcare products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) were set up in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA are the government agency, who are responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA are an executive agency of the Department of Health for the UK.

The MHRA regulate a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering.

The MHRA are responsible for regulating the UK medical devices market.

The MHRA Medical Device regulatory requirements include:


  • UKCA
  • ISO 27001 Information Security
  • ISO 13485, IEC 60601 & IEC 62304
  • Managing Medical Devices Jan 2021
  • Directive 93/42/EEC on medical Devices (EU MDD)
  • Management of In Vitro Diagnostic Medical Devices Jan 2021
  • Management and use of IVD Point-of-Care Test Devices Jan 2021
  • Directive 98/79/EC on in vitro diagnostic Medical Devices (EU IVDD)
  • Directive 90/385/EEC on active implantable Medical Devices (EU AIMDD)
MHRA Logo
Medical Devices Validated By Zener Engineering Services Ltd

Since leaving the EU, the MHRA are developing a robust, world-leading regulatory regime for medical devices that prioritises patient safety. This will take into consideration international standards and global harmonisation in the development of our future system.


ZES provided the MHRA with advice on updating regulatory requirements.

Need Help With MHRA Inspections?

The European Medicines Agency (EMA)

The European regulatory framework ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market.

Medical devices within the EU are currently regulated by three Directives:


  • Council Directive 93/42/EEC on Medical Devices (MDD) (1993)
  • Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)
  • Directive 98/79/EC of the European Parliament and of the Council on in vitro Diagnostic Medical Devices (IVDMD)

To keep up with advances in science and technology, two new Regulations are replacing the three existing Directives in the coming years.

The new regulations for medical devices and in vitro diagnostic medical devices establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety are adopted.

The new EU Medical Device regulatory requirements include:

  • Medical Device Regulation (2017/745)
  • In Vitro Diagnostic Medical Device Regulation (2017/746)

Legacy Standards:

  • CE Mark
  • ISO 27001 Information Security
  • ISO 13485, IEC 60601 & IEC 62304
EU MDR Logo
ZES provided expertise for a new sterile MD manufacturing facility.
Need Help With EMA Inspections?

Medical Device Validation And Project Experience

ZES have significant experience of, and expertise in, the following medical device engineering / manufacturing aspects:


  • Software Validation
  • Achieve UKCA / CE Markings
  • Project Management / Review
  • Information Security to ISO 27001
  • Create from scratch technical files
  • Ensure software complies with IEC 62304
  • Ensure device construction complies with ISO 60601
  • Plan and organize registration submissions and registrations
  • 510k Clearances : Advice, Documentation Generation and Validation
  • Manufacturing Facility Design, Project Management, Installation and Validation
  • ISO 13485, MDR 2017/745, IVDR 2017/746, compliance advice and implementation
  • Liaise with regulatory authorities and prepare meeting packages with relevant agencies
  • Implementation of a suitable management strategy for Medical Device Cyber Security
  • Full new product development lifecycle experience from conception to commercialisation
  • Regulatory advice and support for registration and conformity of medical devices in EMEA regions and emerging markets


For more information regarding our Medical Device Services, contact ZES.

Medical Device Validation And Project Experience

ZES have significant experience of, and expertise in, the following medical device engineering / manufacturing aspects:

  • Software Validation
  • Achieve UKCA / CE Markings
  • Project Management / Review
  • Information Security to ISO 27001
  • Create from scratch technical files
  • Ensure software complies with IEC 62304
  • Ensure device construction complies with ISO 60601
  • Plan and organize registration submissions and registrations
  • 510k Clearances : Advice, Documentation Generation and Validation
  • Manufacturing Facility Design, Project Management, Installation and Validation
  • ISO 13485, MDR 2017/745, IVDR 2017/746, compliance advice and implementation
  • Liaise with regulatory authorities and prepare meeting packages with relevant agencies
  • Implementation of a suitable management strategy for Medical Device Cyber Security
  • Full new product development lifecycle experience from conception to commercialisation
  • Regulatory advice and support for registration and conformity of medical devices in EMEA regions and emerging markets

For more information regarding our Medical Device Services, contact ZES.

Medical Device Validation And Project Experience

ZES have significant experience of, and expertise in, the following medical device engineering / manufacturing aspects:


  • Software Validation
  • Achieve UKCA / CE Markings
  • Project Management / Review
  • Information Security to ISO 27001
  • Create from scratch technical files
  • Ensure software complies with IEC 62304
  • Ensure device construction complies with ISO 60601
  • Plan and organize registration submissions and registrations
  • 510k Clearances : Advice, Documentation Generation and Validation
  • Manufacturing Facility Design, Project Management, Installation and Validation
  • ISO 13485, MDR 2017/745, IVDR 2017/746, compliance advice and implementation
  • Liaise with regulatory authorities and prepare meeting packages with relevant agencies
  • Implementation of a suitable management strategy for Medical Device Cyber Security
  • Full new product development lifecycle experience from conception to commercialisation
  • Regulatory advice and support for registration and conformity of medical devices in EMEA regions and emerging markets


For more information regarding our Medical Device Services, contact ZES.

Pharmaceutical Services Call ZES For MD Expertise
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Don’t just take our word for it...

Medical Device FDA 510k 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

BD Logo

Don’t just take our word for it...

Sterile Medical Device: Manufacturing Facility

"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)

During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.

...... ZES showed considerable knowledge on engineering and validation."

QC/RA Specialist
BD Medical

BD Logo

Don’t just take our word for it...

Sterile Medical Device: Manufacturing Facility

"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)

During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.

...... ZES showed considerable knowledge on engineering and validation."


QC/RA Specialist
BD Medical

Your
Medical Device Experienced ZES Consultant

ZES have worked closely with FDA and MHRA inspectors, to ensure medical device manufacturing facilities have reached the required standard for their first inspection,
with the implementation of quality systems
which take into account cGMP.

Contact ZES for expert help with all aspects of Medical Device Manufacturing.
Contact Options

Your
Medical Device Experienced
ZES Consultant

ZES have worked closely with FDA & MHRA inspectors,
to ensure medical device manufacturing facilities
have reached the required standard for their first inspection,
with the implementation
of quality systems
which take into account cGMP.

Contact ZES for expert help
with all aspects of Medical Device Manufacturing.

Contact Options

Your Medical Device
Experienced ZES Consultant

ZES have worked closely with FDA & MHRA inspectors,
to ensure medical device manufacturing facilities
have reached the required standard for their first inspection,
with the implementation of quality systems
which take into account cGMP.

Contact ZES for expert help with all
aspects of Medical Device Manufacturing.

Contact Options
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