One Month To Go!!! : Med-Tech Innovation Expo '22
Med-Tech Innovation Expo 08th - 09th June 2022 @NEC
In 2022 Med-Tech Innovation Expo is a bigger show packed with even more exhibitors and exciting content focused on med-tech, medical plastics, digital devices, pharmaceutical manufacturing technologies, start-ups and more!
The design and manufacture of medical devices is not a simple process. It requires validated specialist technology, materials, software and components which must be regulated in a much tighter way than for other industries.
New or improved devices, products and solutions in this sector save lives, improve quality of life and quality of care, so we are here to help.
Visit the Med-Tech Innovation Expo to discover the solutions Zener Engineering Services Ltd can provide.
Enter Our Champagne Draw When You Visit The ZES Stand D30
Meet One of the Many Heroes of the NHS @ Stand D30
ONLY ONE MONTH TO GO!!!
Call and see ZES at the Med-Tech Expo in Birmingham UK Sept 2022
Cleanroom Tools
New For 2022
With no pores or cracks to harbour dirt, grime or bacteria, Stainless Steel lets a cleaning solution do all but the toughest cleaning jobs. Bacterial removal and ease of cleanability of all ZES Stainless Steel Tools helps protect the Cleanroom Environment.
ZES Cleanroom Tool Product Details:
- AISI 420 Stainless Steel
- High Strength and Hardness
- Excellent Corrosion Resistance
- Precision Engineering
- Excellent Value
- Free UK Delivery
ZES have a full range of Cleanroom Tools, manufactured to order.
Contact ZES With Your Cleanroom Tool Requirements Today!
Orders Now Being Taken.
Come and talk to ZES about Software Validation
IEC 62304 defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes 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.
ZES Computer Software Validation Services include full life cycle documentation generation and protocol execution, incorporating:
- Site Validation Master Plans
- System Validation Plans and Summary Reports
- Validation Gap Analyses
- Position Statements
- Risk Assessments
- Software Validation
- Spreadsheet Validation
- Cloud Systems
- Automated Systems (PLCs)
- Inventory Management
- Validation Strategy Implementation Adopting a Risk-Based Approach
- Electronic Record and Electronic Signature Assessment and Remediation
- CSV Training Delivered by Industry Experts
Medical Device Validation and Project Experience
ZES have significant experience of, and expertise in, the following medical device engineering / manufacturing aspects:
- Regulatory advice and support for registration and conformity of medical devices in EMEA regions and emerging markets
- ISO 13485, MDR 2017/745, IVDR 2017/746, compliance advice and implementation
- Liaise with regulatory authorities and prepare meeting packages with relevant agencies
- Plan and organize registration submissions and registrations
- Create from scratch technical files
- Full new product development lifecycle experience from conception to commercialisation
- Achieve UKCA / CE Markings
- 510k Clearances : Advice, Documentation Generation and Validation
- Manufacturing Facility Design, Project Management, Installation and Validation
- Ensure device construction complies with ISO 60601
- Ensure software complies with IEC 62304
- Software Validation
- Project Management / Review
- Implementation of a suitable management strategy for Medical Device Cyber Security
- Information Security to ISO 27001
For more information regarding our Medical Device Services, contact ZES.
