NCR and CAPA resolution is critical to any medical device company. This is one of the key areas the FDA looks at when they perform an audit. It’s important to be both thorough in the investigation and timely in corrective and preventive actions. Baymar can support entire NCR and CAPA projects from root cause investigation to designing both a short term immediate fix to a long term preventive fix. Our team can write and execute the necessary verification and validation protocols and update the risk documentation as well. We are experts at working within the restrictive on-market redesign constraints. If field replacement is required, we help ensure it can be done in the field by your service team or the customer as required. We also ensure they have the instructional materials and tools necessary to get the job done. We also make sure the production team has the updated documentation, training, and tools they need to implement the change. Baymar handles every detail to make NCR and CAPA resolution as painless as possible.
Our design transfer team and manufacturing engineers understand lean manufacturing methodologies and apply them to process optimization. We can reduce cycle times and improve quality throughout the process. Whether your goal is to improve quality, reduce cost, or improve delivery, we can help your team exceed your goals.
With many of our customers, we are trained in their quality management system and have the capability of initiating and executing change orders. This takes this time-consuming burden off of your team and moves them to a review role, freeing up their time for more value-added tasks.
Our team has developed significant expertise with the requirements covered by Europe’s new and complex IVD regulation (IVDR), performing a variety of activities meant to make all future and existing products fully compliant with the regulation. Our experience includes conducting gap analysis to determine what’s required to make an existing product fully compliant with IVDR requirements, designing and writing regulatory documentation included in IVDR (e.g. Performance Evaluation Plans, Analytical Performance Reports, Performance Evaluation Reports), assisting with other IVDR documentation requirements (e.g. Intended Use Statements, Scientific Validity Reports, Comprehensive Literature Reviews, Clinical Performance Reports), and updating regulatory risk management documentation to comply with IVDR (e.g. FMEAs, Risk Management Reports), among others.
Managing design changes is one of the specialties best established across Baymar’s team, and doing so from the scientific side of an IVD product or system throughout its lifecycle is not the exception. Besides the managing of engineering changes, our team has experience coordinating and managing design changes that pertain to the scientific side of IVD products, such as: replacement of reagent raw materials, changes to reagents or formulation processes to improve the performance or stability of IVD bulk reagents and assays, among others.
The Baymar team has designed and built hundreds of assembly and test fixtures. We design holding fixtures with smart features such as poka-yoke and symmetry, ensuring your assemblies go together right the first time. Our test fixtures are designed to test subassemblies prior to moving on to the next step, preventing costly rework. We can also ensure you have the necessary documentation to support your master process validation, saving you time in your launch cycle.
If you are in need of inspection fixtures or go/no-go gauges for complex parts or custom assemblies, Baymar can apply our expertise in GD&T, inspection, and sub-assembly testing to deliver high quality inspection fixtures.
Our team of manufacturing engineers have deep experience in equipment validation. We can both write and execute IQ, OQ, PQ and PPQ documentation for your production line, anything from basic fixtures and tools, to complex automation.
All projects at Baymar are managed using the Agile methodology. With an Agile team mentality, Baymar can adapt to project changes in a quick, effective manner. We do this by emphasizing stakeholder involvement and communication.
Our project managers work with your vendors to ensure they are meeting expectations and work through any non-conformances or design issues with them. This includes everything from machined parts to sheet metal to injection molded parts.