When operating in a sector as demanding as medical moulding, quality is not negotiable. With a deep understanding of these challenges, ZEISS presents its medical quality assurance portfolio: a comprehensive and connected portfolio of integrated hardware and software solutions that supports industry standards, helping you thrive in this demanding sector.
Medical plastics perform essential functions for human health, storing and delivering therapeutic compounds to target sites. The functionality of these devices must be guaranteed to achieve the desired therapeutic effect and assure patient safety. To ensure proper production and compliance with industry standards and regulations, medical manufacturers must perform quality control on large volumes of components, process small and delicate features with non-standard geometries, and correctly handle plastics that may be transparent, sensitive, or prone to bending.
Also known as medical combination products, medical plastics either comprise of multiple components, combine multiple products, or may only be used together with a specific separate drug or device.
The ZEISS medical quality assurance portfolio helps you run fast checks on multiple components simultaneously, undertake multisensory inspections of soft and flexible parts, and perform freeform analysis to guarantee the optimum function and design of your assemblies for a wide variety of medical products.
Increasing Requirements to Quality Assurance
As the complexity of a device and the number of individual pieces required increase, the burden of quality assurance increases. For basic plastic components such as the housing of an inhaler, the challenge is to ensure the quality of large production runs and GD&T.
For a medical assembly with multiple plastic pieces, for example syringes, insulin pens or flow control parts, the challenge is to capture the small features of freeform parts. In most cases, the components must be within tight tolerances to ensure reliable mechanic function whilst being manufactured in large batches.
Self-infusion pumps, blood tests, and asthma inhalers with a display are more examples of complex plastic devices with an electronic component. These products often have sensitive surfaces and consist of thin, bending or transparent plastics. Therefore the challenge is being able to perform fast checks on devices with multiple components and materials.
Clearing Regulatory Hurdles with the ZEISS Connected Portfolio
- Proof of Quality
- Guideline Compliance: FDA, MDR, etc
- Data Handling Regulation: FDA 21 CFR Part 11
- Quality Management Regulation: ISO 13485:2016, FDA 21 CFR Part 820
ZEISS offers a comprehensive and connected portfolio of hardware solutions that includes tactile and optical coordinate measuring machines (CMMs), 3D scanners, microscopes, as well as CT (computed tomography) and X-ray solutions. Customers benefit from class-leading resolution, accuracy, measurement speed and powerful automation functions, ensuring continued productivity.
Furthermore, ZEISS software solutions are built from the ground up with regulatory compliance front of mind. All software ensures compliance with ISO 13485 and FDA 21 CRF Part 11 due to its secure user management, integrated audit trails, continuous validation, versioning and protection of documents, electronic signatures, and disaster recovery. This leaves you with more time to focus on your business, with peace of mind that compliance is in hand.
While the understandably tough regulations governing medical products may initially appear prohibitively stringent, ZEISS quality solutions can help you thrive in this demanding manufacturing sector.
For more information about the ZEISS Medical Quality Portfolio, download the medical plastics brochure for free.