Quality and compliance
Our commitment to quality and compliance is fundamental to the experience of the consumers, patients and healthcare professionals who interact with the products we help you to design and develop.
We’ll ensure that your product meets all applicable industry standards and regulations.
Specializing in the field of medical devices, we are experienced in all relevant regulatory requirements and standards globally, including those administered by the FDA and EU MDR.
From early-stage design inputs through to formal verification and validation, our procedures are governed by our ISO 13485 certified Quality Management System and ISO 14971 risk management processes, while our electrical engineering practices adhere to IEC 60601-1 as standard. So, you can be assured that your product innovation is the result of robust and compliant design thinking – with safety, performance, usability and effectiveness front of mind.
Our approach to excellence as standard.
At Ensera Design, we strive for excellence in everything we do, committing to these principles:
- Everyone within our organization knows the importance of meeting client needs, as well as statutory, legal and regulatory requirements.
- We place high priority on offering value to our clients and the communities they serve through world class innovation.
- We foster a culture of teamwork and quality throughout our business.
- We develop good working relationships with our suppliers and collaborate with them to enhance the service we provide.
- We undertake continuous improvement to maintain the effectiveness of our Quality Management System (QMS) in meeting our clients’ expectations and objectives
Data security and privacy
Protecting data, ensuring privacy, and maintaining robust cybersecurity are at the core of everything we do.
Through comprehensive policies and protective measures, we uphold the highest standards of security, privacy and compliance. This commitment safeguards our employees, our clients, and your end users throughout every partnership.
This approach extends to product development too. By following IEC 81001-compliant software development practices, we manage cyber risk proactively. Combining deep risk management expertise with advanced security measures, we protect sensitive data, meet regulatory requirements, and ensure the integrity of the connected medical devices we support.
We can help you take high quality steps forward.
We’re here to help you make high quality and fully compliant products, that bring your healthcare innovation to life in a safe and effective way. Get in touch to discover how we can bring your pharmaceutical, medical device or consumer health project to life.