Engineering Services
Our MedTech engineering services are designed around the unique demands of the industry to ensure your medical devices not only meet user needs but surpass them.
Innovate with full regulatory confidence
Trust Apotech as your MedTech engineering partner
As a trusted partner within the industry, we offer specialised engineering solutions that are designed to meet the unique demands of healthcare innovation.
With a steadfast commitment to precision and innovation, we are prepared to guide you through every stage of the design and development journey – from initial concept to successful commercialisation.
Trusted by top-tier teams worldwide
Verification and validation (V&V)
Verification and validation (V&V) are essential processes during research and development (R&D). They are distinct but complementary activities that ensure your device meets requirements, functions effectively and is safe for its intended use.
While often confused, they serve distinct purposes in ensuring that devices meet regulatory requirements and user needs.
- Design verification confirms that the design outputs meet the specified design inputs and that the device is designed correctly.
- Design validation demonstrates that the device's design meets user needs and intended uses, while ensuring that the right device has been designed.
At Apotech, we understand the significance of verification and validation processes in achieving regulatory compliance and ensuring patient safety. Our experienced team specialises in guiding you through these essential stages, providing comprehensive support in planning, executing, and documenting verification and validation activities.
Through our tailored approach, we can support you in software verification and validation through:
- Defining clear design inputs
- Developing robust verification protocols
- Conducting thorough validation testing
Human Factors/Usability – IEC 62366-1:2015
Usability refers to the extent to which a device can be used effectively, efficiently and satisfactorily by intended users in specific contexts of use. It encompasses various aspects of user interaction, including ease of learning, ease of use, efficiency, memorability, error prevention and user satisfaction.
IEC 62366-1:2015 is an international standard that specifically covers the application of usability engineering and is the overlapping standard for FDA, the European Commission and other regulatory bodies.
Europe’s Medical Device Regulation (MDR) is a little less specific about usability requirements, as this is covered largely in the General Safety and Performance Requirements. However, this does include requirements for product validation and usability-related activities, which must be documented in a manufacturer’s technical file.
The regulation also emphasises the need to collect and evaluate usability data as part of a manufacturer’s post-market monitoring and evaluation process.
Our team can offer support in:
- Usability/Human Factors training
- User need analysis
- User-centred design (UCD)
- Human factors engineering
- Prototype and testing
- User interface design
- Instructions for use
- Usability engineering report
ISO 11135
ISO 11135:2014 specifies requirements for the application of ethylene oxide (EO) sterilisation of devices, ensuring that they are safe and effective for patient use. This standard covers various aspects of the sterilisation process, including the selection of appropriate sterilisation parameters, the validation of sterilisation cycles and the monitoring of EO residuals.
At Apotech, we can provide expertise in interpreting the standard's requirements, developing robust sterilisation processes, conducting validation studies and establishing quality management systems to ensure compliance.
We can also offer guidance on documentation practices, training programs and ongoing monitoring to maintain the effectiveness of EO sterilisation processes. By partnering with us, you can navigate the complexities of ISO 11135:2014 more efficiently and effectively, and ultimately improve the safety and quality of your devices.
ISO 11137
ISO 11137-3:2017 outlines the criteria for validating and managing radiation sterilisation methods for healthcare products, with a specific emphasis on dosimetry considerations. This standard plays a crucial role in ensuring the effectiveness and safety of radiation-based sterilisation processes in healthcare settings.
Our team at Apotech specialise in ISO 11137-3:2017 and can provide comprehensive support in implementing these requirements – from conducting dose audits to establishing appropriate validation protocols to ensuring compliance with regulatory standards.
We can also help you navigate the complexities of radiation sterilisation, improve product quality assurance and uphold regulatory compliance effectively.
Excited to work together on your next project?
Our range of IVD auditing services
At Apotech, we offer a comprehensive range of auditing services to suit your exact needs. From remote audits to MDSAP audits, we can also tailor our approach depending on your requirements, helping support you along each step of the way.
Featured case studies
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…