Manufacturing & Process Qualification
SechMed ensures a seamless transition from development into production, bridging the gap between prototype success and efficient and compliant production. We support every aspect of the design transfer process, from preparing comprehensive documentation packs and coordinating supplier selection to developing and executing process validation protocols. Our approach delivers production methods that are robust, repeatable, and efficient by ensuring compliance with regulations & standards, and with industry best practice.
With SechMed, you can scale confidently from prototype to production, knowing your processes are efficient, compliant, and built to last.
Supplier Selection
SechMed supports the identification and control of reliable suppliers to ensure consistent quality and compliance. We help assess technical capabilities, regulatory track records, and quality management systems, and establish quality agreements where needed. By building and formalising strong relationships with critical suppliers from the outset, we reduce risks associated with procurement and ensure the foundations for efficient scale-up are in place.
Design Transfer
Successful scale-up requires more than just a finalised design; it demands a structured handover to manufacturing. We prepare comprehensive design transfer packs, including drawings, specifications, and assembly instructions, to ensure nothing is lost between development and production. By coordinating closely with manufacturing partners, SechMed helps maintain design intent, product performance, and compliance as the device moves into production.
Process Validation (IQ/OQ/PQ)
Robust process validation is central to regulatory compliance and product consistency. SechMed develops and executes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols tailored to your device and manufacturing processes. We ensure every step is documented, repeatable, and verifiable, giving regulators and clients confidence that production consistently meets specifications and safety requirements.
Packaging & Sterilisation Validation
Safe and compliant packaging and sterilisation methods are essential for product integrity and patient safety. SechMed works with packaging and sterilisation providers to develop packaging that is validated to ISO 11607, and applicable sterilisation standards. This ensures packaging robustness during transportation & storage and confidence in the integrity of the Sterile Barrier System.
Quality System Integration
Scaling a device requires alignment between stakeholders’ quality management systems. SechMed supports the integration of production processes into ISO 13485-compliant systems, ensuring documentation, traceability, and change control are compatible. SechMed can also assist in preparing for audits and inspections, giving confidence that manufacturing operations are fully aligned with regulatory requirements and sustainable for long-term production.
Contact us.
info@sechmed.ie
Unit 4 Sunnybank Centre,
Upper Dargle Road,
Bray,
Co. Wicklow,
Ireland,
A98E339