Medical Device Plastic Injection Molding
Whatever your device requirements are, PreciKam can help. Located in Canada, we are experts in plastic injection molding for medical devices and equipment in North America. We manufacture systems for the delivery and storage of drugs and other pharmaceuticals, medical testing devices and consumables, and a variety of miscellaneous parts used in various therapies and treatments.
When lives are at stake, precision should never be optional
PreciKam has built a solid reputation in the medical industry. Our ISO Class 7 clean rooms are used to produce devices for the health and safety of people. Serving the medical industry is a privilege that we never take for granted.
Our ISO13485:2016 clean room teams are proud of the procedures that we follow to ensure the devices we manufacture for the health and safety of others meet or exceed our customer-specific requirements. Serving the medical industry is aligned with our core values and makes us extremely proud.
When lives are at stake, precision should never be optional
PreciKam has built a solid reputation in the medical industry. Our ISO Class 7 clean rooms are used to produce devices for the health and safety of people. Serving the medical industry is a privilege that we never take for granted.
Our clean room teams are proud of the procedures that we follow to ensure the devices we manufacture for the health and safety of others meet or exceed our customer-specific requirements. Serving the medical industry is aligned with our core values and makes us extremely proud.
When lives are at stake, precision should never be optional
PreciKam has built a solid reputation in the medical industry. Our ISO Class 7 clean rooms are used to produce devices for the health and safety of people. Serving the medical industry is a privilege that we never take for granted.
Our clean room teams are proud of the procedures that we follow to ensure the devices we manufacture for the health and safety of others meet or exceed our customer-specific requirements. Serving the medical industry is aligned with our core values and makes us extremely proud.
Risk Management Key Factors
The medical, pharmaceutical, and scientific devices produced at PreciKam meet the strict requirements of our medical, pharmaceutical, and scientific customers. A reliable and highly qualified manufacturer to produce these medical devices must understand that the key factor in medical device plastic injection molding: Risk Management!
Regulatory Compliance
Certifications such as ISO13485:2016, Certified Class 7 and Class 8 Clean rooms, and a Bioburden Class C Certification ensure we meet the regulations and standards set forth and regularly monitored by regulatory bodies. Adherence to these standards is a prerequisite for medical device plastic injection molding as it ensures the safety and efficacy of devices that keep people safe.
Quality Control
Our outstanding Risk Management and control systems ensure consistency and reliability in production. Extensive industry knowledge and rigorous Quality Management go into our scientific and medical equipment plastics.
Expertise
Our highly educated, empowered team comes with years of medical documentation preparation and control experience. Decades of medical mold making, molding and assembly experience allows us to understand the requirements of medical device plastic injection molding. Our team will provide guidance and support throughout the entire production process.
Production Capabilities
Our well-protected IT infrastructure, in-house design and manufacture of molds, equips us with the equipment, capacity and expertise needed to meet the demands of the medical industry. PreciKam offers extensive, in-house, post-molding services including assembly, printing, finishing, and shipping.
Material Selection
Our experience and extensive network of suppliers allow us to offer our customers technically engineered resins that are ideal for producing their device.
Partnerships
Approved and rigorously selected, our strategic partnerships ensure production stability. Some of these are accredited back-up molders, complex medical converters, production 3D printers, in-mold assembly designers, sophisticated machine shops, and technical resin suppliers. However, PreciKam will always remain transparent when a partner is used and will always remain the single point of contact and responsibility.
Design Support
Our in-house design and manufacturing of molds is matched by our commitment to provide design support that helps optimize your medical device plastic injection molding, making it manufacturable at scale.
Traceability
Our ability to manage medical documentation and implement traceability systems ensures that all devices have a respective production history and can be traced back to their source, if required. Learn more about traceability.
Controlled environments make patient use possible
A tightly controlled environment positively impacts patient outcomes and well-being. This is the foundation of PreciKam’s raison d’etre. Medical devices must meet strict quality standards to ensure they are safe for patient use. The creation of highly precise and complex parts allows the medical industry to continue serving our population.
The ability to produce parts within bioburden and air quality requirements is another cornerstone of medical device plastic injection molding. The cleaner and more controlled an environment is, the lower the risk for usage in the medical or pharmaceutical sector.
Controlled environments make patient use possible
A tightly controlled environment positively impacts patient outcomes and well-being. This is the foundation of PreciKam’s raison d’etre. Medical devices must meet strict quality standards to ensure they are safe for patient use. The creation of highly precise and complex parts allows the medical industry to continue serving our population.
The ability to produce parts within bioburden and air quality requirements is another cornerstone of medical device plastic injection molding. The cleaner and more controlled an environment is, the lower the risk for usage in the medical or pharmaceutical sector.
ISO 13485 Injection Molding
For our customers in the medical and health sectors, ensuring quality and safety is paramount. PreciKam’s ISO 13485 injection molding stands as a beacon of trust, guaranteeing parts crafted with utmost precision, care, and compliance. Dive into the rigorous standards that shape a safer tomorrow with every mold we craft.
Specialized Medical Devices We Assist With
At PreciKam, we deliver high-precision plastic injection molding for a wide spectrum of medical devices. These are essential products whose parts and processes may be complex, but whose purpose is simple: keep people safe.
Drug Reconstitution
Devices
We manufacture components for advanced drug delivery systems such as auto-injectors, dual-chamber devices, and pen-style delivery systems. With ISO 13485 certification, clean-room molding, and complete assembly services, we ensure performance that meets the highest regulatory standards.
