Expert Consulting Solutions for Business Growth
Our Services
We specialize in designing and deploying high-efficiency, regulatory-compliant injection molding cells for medical device manufacturing. Our end-to-end service covers every phase — from machine sizing and robot integration to process validation and operator training — ensuring your cell delivers repeatable quality, minimized cycle times, and maximum OEE.
Leveraging experience with Arburg, Engel, and Fanuc systems, and expertise in both PC and LSR molding, we develop optimized layouts and automation strategies that reduce manual handling and align with ISO 13485, FDA 21 CFR 820, and ISO 14644 cleanroom standards. Whether you’re installing your first press or transitioning to a lights-out environment, we ensure your cell performs flawlessly from day one.
Our mold design service ensures precision, longevity, and regulatory traceability from concept to qualification. We bridge the gap between design intent and manufacturability through scientific DFM reviews, Moldflow simulations, and tooling validation protocols (T0–T3).
We help you select the right tooling strategy — single-shot, two-shot, or LSR — and collaborate closely with your mold maker to ensure critical dimensions, surface finishes, venting, and ejection meet medical-grade standards.
From prototype to production tooling, we deliver a validated, documentation-ready mold package that accelerates time-to-market while maintaining compliance and consistent part quality.
We build and optimize Quality Management Systems (QMS) that meet the stringent requirements of ISO 13485 and FDA 21 CFR Part 820 — ensuring your manufacturing operations are audit-ready and globally compliant.
Our consulting includes end-to-end system design, documentation architecture, supplier quality programs, and risk management per ISO 14971.
Whether you’re a startup seeking certification or an established manufacturer aiming for higher maturity, we help you establish a scalable QMS with controlled procedures, CAPA systems, internal audit programs, and training modules tailored to your device class and production environment.
We craft comprehensive Equipment Requirement Specifications (ERS) that define every mechanical, electrical, software, and regulatory expectation for your equipment suppliers.
Our structured ERS ensures vendors fully understand your process parameters, material constraints, automation interfaces, and validation deliverables before quoting.
We also manage vendor selection, using weighted scoring matrices to evaluate technical fit, compliance readiness, cost, and service capability.
This service reduces supplier misalignment, mitigates project delays, and ensures your capital equipment investments yield measurable ROI — all while meeting global regulatory standards.
About
our company
Sidec Consulting is a specialized engineering and manufacturing consultancy dedicated to the medical device industry, helping companies bridge the gap between product design and scalable, compliant production.
With deep expertise in Injection Molding Cell Setup, Mold Design, Quality Systems, and Manufacturing Engineering, we partner with OEMs, contract manufacturers, and startups to accelerate new product introduction and operational excellence.
Our mission is to enable clients to achieve world-class manufacturing performance — combining technical precision, regulatory compliance, and smart automation. Whether you’re building a new cleanroom facility, validating a new process, or optimizing existing production lines, Sidec Consulting brings structured methodologies, data-driven decision-making, and hands-on experience to deliver measurable results.
We operate at the intersection of engineering innovation, regulatory compliance, and operational efficiency — ensuring every process we design is capable, compliant, and sustainable.
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