At Medbio we contribute our knowledge, expertise, and the latest technology to provide products that improve the quality of life.
We are an ISO 13485:2016 certiﬁed, FDA Registered contract manufacturer oﬀering innovative manufacturing solutions for the medical and biotechnology industries. We specialize in precision injection molding, assembly, packaging, project management, and design support. We have numerous certified ISO Class 7& 8 cleanrooms and white rooms for molding and assembly. We have flexible capacity to handle major projects or small custom orders. We mold most medical grade thermoplastics, including implant grade “PEEK and all of our silicone molding is done in it’s own facility.
Our engineering and management professionals average over 300 years of experience in medical device manufacturing. We have an excellent reputation for delivering quality, service, and value, and have grown from customer referrals. Strategic partnerships and conducting business with integrity allows Medbio and our partners to achieve growth, success, and profitability. With numerous locations around the country, we have the expertise and passion to solve your most complex problems.
Please take our virtual tour @ www.medbioinc.com
Full Service Medical Contract Manufacturer
- Product Development
- Project Management
- Precision Tool Design & Construction
- Cleanroom Precision Injection Molding
- Cleanroom Assembly & Packaging
- Laser and Ultrasonic Welding – Gluing/Solvent Bonding
- Pad Printing and Hot Stamping – Laser Etching
- Pouching, Tray Sealing, Bagging, and Shrink Wrapping
- White Room Molding
- Flexible Capacity
- Rapid Turnaround
Medical Injection Molding
- Medical Grade Thermoplastics
- Implantable Thermoplastics
- Two-Shot Molding
- Insert & Over Molding
- Micro Molding
- Thin-walled Parts/Coining
- Hand-loaded Cores to Full Automation
- Scientific Process Development (RMT)
- Kistler Cavity Pressure Sensors
- In-house Tooling
Quality and Metrology
- ISO 13485:2016 Certified
- Fully Capable Metrology lab
- Full Annual Internal Audit Schedule
- Quality programs tailored to suit individual customer’s requirements.
- Part Measurement
- Measurement Systems Analysis
- First Article Inspection
- Capability Studies
- Product Qualifications
- Fixture Qualifications
- Process Qualifications (IQ, OQ, PQ)
- Multi-run Validations
- General Surgery
- Cell Growth
- Cardiovascular Surgery
- Neurological Surgery
- Wound Care
- Knowledge & Solutions
- Integrity & Passion
- Quality & Value
FEATURED ARTICLES AND DOWNLOADS
Medbio’s focus on quality extends from our molding teams into assembly and packaging. Our assembly team strictly follows the validated process to reduce part-to-part variation, and provides the quality our customers expect while packaging individual devices or kits.
There are many options when it comes to manufacturing plastic parts. Each process has it's pros and cons. Knowing your quantity goals, timelines, and budget are all important factors to take into consideration from the beginning.
Headquartered in West Michigan, Medbio is a contract manufacturer offering innovative manufacturing solutions for the medical and biotechnology industries. Medbio specializes in precision injection molding, assembly, and packaging.
MedBio provides three levels of validation. These segments allow you to quickly reference the degree of validation
that you need, and implement it as needed. This gives your team valuable time to focus on product design and commercialization.
Precision injection molding ensures that, regardless of the annual production volumes, the process can be consistently repeatable. This brochure from MedBio breaks down the steps to getting the process correct the first time.
Using medical-grade silicone offers a number of benefits for medical components, including meeting FDA regulations, superior gas permeability, excellent bonding and overmolding capabilities, as well as high flexibility and tear resistance.
Meeting the FDA regulations for medical device usage, medical grade silicone properties are inherently inert to bacteria, mold, and fungi.
MedBio provides design modifications and enhancements, tooling design, manufacturing automations, quality assurance, assemble, and packaging assistance. Their engineering team consists of plastic, mechanical, electrical, and biomedical engineers.
Medbio offers a number of tips to follow for a successful startup in designing and producing injection-molded parts.
Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Medbio offers a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in in the molding process.