Explore the importance of purchasing controls in the medical device industry. Learn how effective supplier assessment, record-keeping, and regulatory compliance ensure patient safety and product quality.
The medical device industry is a critical partner for providing innovative patient-centric solutions that improve outcomes and will be the device industry model for value-based healthcare. However, to maintain the highest standards of safety and efficacy for medical devices, it is vital that there are strong quality control measures in place at every stage of a product’s lifecycle. Purchasing controls are an integral component of the Quality System Regulation that is implemented for the purpose to maintain quality and integrity of raw materials, components, as well as services purchased to produce medical devices.
Meaning of Buy Controls
There is a wide variety of medical devices, from simple bandages to complex implantable devices. Despite their complexity, medical devices need to maintain a consistent quality to make sure that they are safe for the patient. Purchasing controls play an important role in the quality management system, which are used to control sourcing and acquisition of components and services that will be transformed into device manufacturing, assembly or distribution.
Assessment of Suppliers E. Contractors & Consultant Evaluation
Key to purchasing controls: Purchasing controls at their core start with the proper assessment and approval of suppliers, contractors, and consultants. These entities must be evaluated by manufacturers based on their competency and the requirements specified, specifically for manufacture and quality aspects. The suppliers must be evaluated on parameters such as their past record, quality certifications, technical capability and financial stability. Choosing to work with reputable and qualified suppliers can provide an assurance that the manufacturers are using components appropriate for their medical devices.
Control and Record Keeping Definitions
Lastly, a very important one step would be to define the overall level of control that will apply on products and services as well as over selected entities called suppliers/contractors/consultants. This control ensures that the quality and consistency of purchased components meet the desired standards. Manufacturers need to lay down strict modalities for quality assurance, product specifications and on-going monitoring to ensure complete compliance with the stipulated requirements.
Purchasing Controls must have A Complete and Organized Paper Trail, record the details of suppliers, contractors and consultants they list as acceptable. These records both maintain a record for historical reference and prove compliance during regulator inspections.
Accurate Purchasing Data:
Buying data are needed within the regulation and represents a comprehensive statement of all the described acquisition or received services.. This information should be up-to-date, easy to understand andvailable to the concerned parties. The above is what a good purchase order data system does — tracks product requirements, quality elements and supplier information to make the process of procurement simpler.
Agreement and Notification:
Manufacturers must have in place agreements with suppliers, contractors and consultants to ensure transparency and smooth collaboration. Appropriate provisions should be written in to these agreements stipulating suppliers to inform the manufacture of changes in their product or services as appropriate and without delay. In other words, this mechanism of notification permits the manufacturer to determine whether these changes might affect the quality of the finished medical device. This information can allow manufacturers to prepare in advance for potential changes by re-evaluating or validating, if required, procedures and methods in order to ensure continued product quality and regulatory compliance.
Ensuring Compliance with QSR:
Quality System Regulation compliance is not only a one-time event. It requires continuous dedication. An audit, assessment and documentation review are a part of an enhanced quality management system which every manufacturer should do. They not only help to ensure compliance with purchasing controls but also send a message of active quality assurance.
All regulatory bodies have a crucial role in ensuring that good quality standards are maintained within the medical device industry. When FDA is considering approval or clearance of your product, any failure to comply with QSR or one of the design control requirements set forth can lead to a delay in marketing and distribution.
Conclusion: The Importance of Purchasing Controls in Medical Devices
All medical devices sold and marketed in the US are subject to what are referred to as the purchasing controls part of Quality System Regulation. Manufacturers can guarantee the high safety, quality, and reliability of medical devices only by conducting comprehensive supplier assessments, setting up control mechanisms, keeping records, and creating accurate documentation about purchasing data. Compliance with these controls is important to both reassure patients, healthcare providers, and regulatory bodies as well as for the greater good of the healthcare industry by delivering safe and effective medical devices.
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