In the medical device manufacturing industry, regulatory compliance is fundamental to patient safety, product performance and long-term commercial success. For medical device OEMs, selecting an injection moulding partner is therefore about far more than cost or capacity. The right plastic moulder must operate as an extension of the OEM’s quality system, with the processes, and documentation required to meet stringent regulatory expectations.
In this blog post, we will help you to understand the benefits of partnering with a compliant plastic injection moulder to reduce risk while expediting market entry and simplifying regulatory processes.
Fully certified Quality Management System
As required by regulatory bodies, your company must have a certified Quality Management System. For medical device manufacturing, ISO 13485 certification is typically required. Many manufacturers operate management systems aligned with ISO 9001 principles and may also hold ISO 14001 certification alongside it.
Your medical device moulding partner should have a robust Quality Management System that is applied to every area of the business, not just documented on paper.
OGM’s Quality Management System is implemented, audited and certified to ISO 13485. This ensures all programs are validated and controlled so they are repeatable, traceable and controlled. Documented procedures for document control, CAPA (Corrective and Preventive Action), internal audits, supplier management and non-conformances give OEM’s piece of mind that their quality risks are being controlled.
Validation and process control
Medical device components must be manufactured using validated processes. How stringent the validation depends on the application and the required legal framework such as UK Medical Devices Regulations. Medical plastic moulders should be proficient with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
OEMs should expect their moulding company to:
- Support or lead process validation activities
- Define critical process parameters and acceptance criteria process parameters
- Provide documented evidence that processes operate consistently within defined limits
OGM collaborates with customers throughout every stage of a product’s lifecycle especially validation. We help create robust and repeatable moulding processes through joint development and validation. Continuous process monitoring through SPC, capability studies and trend analysis allows validated processes to remain in control during the product lifecycle. This is what regulators expect.
Material traceability and control
Medical devices often involve strict requirements for material selection. At a minimum, a compliant injection moulder must be able to prove control of raw materials through:
- Approved polymers graded for medical use
- Complete batch & lot traceability
- Segregation of materials
OGM has stringent controls on materials which allows full traceability from resin receipt to finished moulded parts. All material and supplier changes go through change control, backed up by risk assessment and revalidation if necessary, ensuring regulatory compliance and device performance.
Cleanroom & controlled manufacturing environments
A lot of medical devices that are moulded require controlled environments to reduce the risk of contamination. The amount of control required in an environment depends on the end application.
There should be clear justification for cleanroom classification from a compliant moulder, including demonstrated control of:
- Temperature and humidity
- Flow of personnel & gowning procedures
- Material flow and cleaning schedules
- Air Changes per hour
- Etc.
At OGM, we maintain dedicated medical manufacturing facilities, such as cleanroom injection moulding capabilities. Through regulated environmental monitoring, validated cleaning processes, and qualified personnel we help assure product quality stays compliant to customer specification.
Documentation and regulatory filings
Regulatory filings are only as good as the documentation that supports them. Injection moulders should have the capability to produce documentation that can substantiate technical files, DHF’s (Design History File) and DMR’s (Device Master Records).
Examples include:
- Process validation records
- Material certifications and statements of conformity
- Inspection, test and batch records
- Change history
OGM follows a documented change process to provide early notification to OEMs. Risks are clearly identified and communicated, and changes are implemented only upon approval. Assuring regulatory standing and supply chain stability.
Change control and risk management
Medical device regulators require robust change control. OEMs should ensure their moulding partner has a documented change management process in place for tooling, material, processing and suppliers.
OEMs are notified as early as possible of a change that will be required, risks are assessed openly, and changes will not be made until they are approved to an agreed standard with the customer. Ensuring regulatory status and supply remain intact.
Training, competence and quality culture
People are just as important as processes when it comes to compliance. The best moulding partners are those that invest in training and develop a culture focused on quality first-time.
At OGM, all personnel involved in our medical programmes are provided with regular training suitable to their specific responsibilities. This process enables individuals to understand procedures which lets them follow them and helps our organisation achieve ongoing improvement. Our culture of accountability and transparency enables us to identify potential problems early and maintain continuous compliance.
Partnering with the expert medical injection moulder
To medical device OEMs, the ideal injection moulding partner excels technically and is mature on regulatory matters. That compliant moulder can play a pivotal role in not just producing your components, but safeguarding patients, brands and regulatory approvals.
OGM’s experience with regulated medical device manufacturing, validated processes, cleanroom production and ISO 13485-aligned quality systems mean the company is poised to be the dependable partner medical device OEMs want for compliance and long-term support.
Designing or scaling your medical device and looking for a compliant plastic injection moulding partner? At OGM we can assist you from ideation through to validated production. Contact us to discuss your medical moulding needs and see how we can use our regulatory knowledge to minimise risk, speed up time to market and ensure compliance from day one.