Roncadelle Operations is a MedTech manufacturer and CDMO partner specializing in safety injection systems and pharmaceutical packaging.
Through our SafeR® platform, we develop innovative solutions designed to eliminate needlestick injuries—without changing clinical practice.
In parallel, we support our partners from concept to industrial-scale production, delivering RTU systems, drug delivery devices, and primary packaging with precision and reliability.
We don’t just develop products — we industrialize them.
Roncadelle Operations S.r.l., headquartered in Brescia, Italy, develops and manufactures advanced medical devices, components, and pharmaceutical packaging. Our brand vision—MedTech Solutions – Engineered to Protect—guides everything we do.
Our proprietary SafeR® product line includes passive safety syringes and passive needle-guard systems for pre-filled syringes, engineered for Safe Injection and Smart Protection in demanding clinical environments. All SafeR® products comply with ISO 11040-7 and ISO 23908 standards and are FDA 510(k)-cleared, ensuring recognized safety and performance benchmarks.
Beyond our own portfolio, Roncadelle Operations is a trusted CDMO partner to global pharmaceutical and medical-device companies. We integrate precision molding, automated assembly, and packaging under cleanroom conditions to deliver consistent quality, full traceability, and scalable manufacturing capacity—Performance You Can Trust.
Along with over two decades of ISO 13485 quality management experience and more than 15 years of experience in medical device production, Roncadelle Operations gives you the benefit of our state-of-the-art facilities, including the very latest in injection molding and assembly, along with the following capabilities:
Material feeding automatic system: #10 Injection Machines (150 to 320 ton)
High-speed automatic metal forming machine (50 to 500 pcs/min)
Versatile high-speed assembly lines Manufacturing process control automation
Automated lines Boxing system Palletizing robots Filming machine
ISO7 Clean Room
Production Area
Warehouse
Offices
Green Area / Plant Expansion
Certified sustainability & mass balance chain of custody
ISCC-PLUS-Cert-DE143-33300477
Certified quality management system for medical devices
EU Regulation 2017/745 compliant medical devices
Cert. ITH 24091691
Cleared Class II medical device (Sefer system)
K221234
All certifications and supporting documentation are available via our secure Documentation Center
Need more information?
Our fully-configurable MES platform uses AI tools and the latest software technologies to run an intelligent factory, incorporating:
Machinery Integration
Production Quality
WH Management
Production KPIs
Our fully-configurable MES platform uses AI tools and the latest software technologies to run an intelligent factory, incorporating:
Meet the experienced leadership team driving innovation, safety, and growth in smart drug delivery and MedTech manufacturing solutions.
