WHAT WE DO

From a sketch to an actual commercial product, our focused expertise and extensive industry experience allows us to customize our development approach for you. Each project gets the quickest learning curves and most efficient timelines.

Our proprietary 5-Phase product development process aligns 25 years of best practices for nimble product development with the rigor required by the FDA. The result is an efficient and risk mitigated path to commercialization.

Our prototype development process compresses delivery time into days or weeks versus months. We can design a 3D model in CAD, let it 3D print overnight, test it first thing in the morning, CNC machine it during week, and injection mold production parts by the end of the month.  This accelerated process saves you time and cost throughout each phase of your project, from concept to clinical. It’s all about flexibility.

• Project management
• Design history file (DHF) development
• Verification and validation
• Risk management
• High- or low-volume prototypes
• Customized creation of almost any kind of prototype, from a one-off model for benchtop testing to a fully documented cleanroom build
• Package design and UDI compliant label development

Before you can bring a critical medical device to market to help enhance – and save – lives, you need to be certain it’s right and ready. Our compliant design verification and validation process, ensures your device is meticulously tested and compliant with all applicable international standards to fast track you through regulatory submissions and get to market fastest and safest.

Our highly qualified team of specialists includes experience in sterilization validation, biocompatibility testing and justification, usability studies, packing validation, shelf-life studies and performance testing. Need a test as unique are your device? Biorep engineering teams will design testing protocols and equipment for it.

Early verification and validation testing are indispensable for risk reduction, ensuring device efficiency and safety. It enables engineers to promptly detect and resolve any issues. Proper verification and validation by an experienced team is essential. Inadequate or excessively frequent testing can lead to substantial costs, while delaying testing or neglecting critical aspects may require an expensive redesign, potentially delaying FDA approval. Since contract design and manufacturing are our specialties, you can be confident in production outcomes at every step in the process.

Identifying and mitigating risks early in the design and manufacturing process is not only a requirement for regulatory bodies but is key to a streamlined device launch as well. Following ISO 14971, our team of qualified professionals can create the Risk Management File from design to manufacturing, ensuring that risk mitigation strategies are integrated into every aspect of your device development: from design to usability to manufacturing.

Biorep maintains an extensive vendor network of industry-recognized and approved suppliers to increase efficiencies for our customers.

Our effective supplier change control management provides proactive notification of proposed supplier changes to you. Our process can establish minimum and maximum inventory levels to further decrease costs and reduce lead times. By optimizing order quantities, Biorep is able to manage costs and ensure on-time delivery.

Our ERP system tracks raw materials, finished goods, and work in-process (WIP) so you always have an up-to-date status of where your product is at any time.

Two of the biggest hurdles to getting a new medical device into the market are the time and expense that it takes to validate a cleaning protocol, design and validate a medical device packaging system, and validate a sterilization process.

Our solutions save a valuable amount of time, money, and resources. This provides our customers a more efficient path to bring their products to market.

“Our pre-validated solutions save a valuable amount of time, money, and resources. This provides our customers a more efficient path to bring their products to market.”
– Felipe Echeverri, CEO, Biorep Technologies Inc.

Bclean® is a family of validated cleaning protocols that have been shown to be effective in removing manufacturing residues from CNC machined and injection molded components. The protocols cover complex part geometries with the most common engineering resin families. Most medical device components will be typically covered under one of our Bclean® pre-validated protocols.
Our BCLEAN® capabilities include:

• Ultrapure DI water system
• Ultrasonic cleaning
• IPA wipe or dip
• Cleaning process validation studies
• Cleaning validations for product families

Bsterile® is a family of gamma and Ethylene Oxide (EtO) sterilization validations for different bioburden counts at different sterilization dosages and ranges. Testing includes a determination of bioburden, bioburden recovery method validation, and bacteriostasis/fungistasis testing.

Bsecure® pouches can be customized to the needs of a specific component by adjusting the length and width of the pouch. This flexibility of customization offers a wide range of options for pre-validated packaging.

A seal validation has been completed with Poly-Tyvek® pouches for the Bsecure® offering, along with 3-year accelerated aging testing with Gamma sterilization and complete validation reports.

Bsecure® offers flexible package options, including Tyvek® lid stock, standard label stock, IFU paper stock and SBS shelf boxes to deliver a complete package system.

Whether automating a single step or your entire workflow, our solutions will improve your productivity so you can focus on what really matters.

We have top-notch machine designers, full fabrication capability, and access to the latest manufacturing technology. We’ll help you develop multi-axis motion systems, microplate instrumentation, liquid handling, machine vision systems, and custom software control systems to deliver accurate, reliable results.

At Biorep, we have an ISO 7, Class 10,000 cleanroom, validated equipment, highly trained technicians, and ISO documented procedures to meet your individual assembly, kitting and packaging specifications.

Our skilled technicians complete assemblies with meticulous accuracy to handle even your most complex assembly, while controlled and verified through our Quality Management System, to provide complete traceability.

Whether we’re assembling 1 part or 1,000 into your final configuration, we will get the job done on time, every time.

Assembly Capabilities:

• Medical Tray and Pouch Sealing
• UV bonding
• Riveting
• Kit assembly (kitting)
• Instrument assembly
• Solvent & adhesive bonding
• Temperature & time sensitive materials handling
• Tubing sets (cutting & fitting assembly)
• Crimping
• In-process Inspection
• Electronics assembly (wire-harnesses, soldering)
• Sterile Packaging
• Inspection

“The whole team jumped in from the beginning. They introduced tooling and packaging strategies in our first meeting. Who else does that?”
– Dr. Siddarth Rawal, COO, Circulogix

Engineering Validations

Before you can bring a critical medical device to market to help enhance – and save – lives, you need to be certain it’s safe and effective. Along with a commitment to absolute quality standards, our medical device contract manufacturing offers rigorous process validation.

We are:

• FDA registered as a manufacturer
• FDA 21 CFR Part 820 compliant
• ISO 13485:2016 certified
• Proficient in Class I and II devices
• Good Manufacturing Practice (GMP) compliant

Using empirical data to understand and control all sources of variation that can affect product quality, our medical device contract manufacturing team proves out and provides documented evidence your product will meet specifications and quality attributes. And we provide all the documentation needed for your design and device history files (DHF), and device master record (DMR).

Our highly qualified team of specialists includes certified packaging professionals and quality engineers. They are experienced in medical device process validation methodologies, validation sampling techniques, Geometric Dimensioning and Tolerancing (GD&T), scientific process development, and sterilization management.

In addition to providing standard incoming inspection, Biorep also offers Critical Inspection services, as well as in-process, manufacturing inspection.

Critical Inspection of medical devices comes with rigorous requirements. Biorep has the expertise, experience and equipment to help ensure your product meets these criteria.

We offer:

• Standard (ANSI Z1.4, Z1,9) and custom sampling plans
• Gage R&R (Repeatability and Reproducibility) analysis of critical measurement methods
• Custom gage and fixture design

In addition to contract sterilization services, Biorep coordinates contract laboratory testing services including, testing within a validation, as well as for routine monitoring purposes. Biorep has established long-term relationships with several ISO/IEC 17025 accredited contract testing laboratories that are proven to be highly qualified and reliable.

Partnering with Biorep for laboratory testing helps you reduce the time and costs associated with managing an additional vendor.

For better or worse, Quality Events happen. Responding quickly and efficiently when problems arise is key to successful commercialization and long-term device life. However, having a fully established quality team is not always an option.

Biorep’s Quality team can act as extension of your team, being the work force you need, when you need it. We have a streamlined ISO 13485: 2016 approved process in addition to over 25 years of experience to handle field or manufacturing events as they occur.

Quality Management systems are not your core strength. Creating a Quality Management System from scratch can be an extremely expensive, long, and draining task taking away key resources from your device development and launch. Quality Management Systems is at the core of what we do. We can design and implement the right-sized Quality Management System for your team.

Your Quality Management System should grow as you grow. Biorep is there for you each step on the way; we will continue to support as needed by conducting your internal audits or even participating in regulatory audits as needed.

Regulated bodies are always evolving and adding more stringent requirements every year. Keeping up with requirements from all the different regulatory bodies can be overwhelming. Utilizing Biorep’s team of regulatory experts to manage your regulatory correspondence gives you peace of mind. We will ensure your information is always up to date and you are kept informed of any changes which could have an impact.

The success of your enterprise hinges on the strategic approach you adopt for 510(k) clearance or CE Mark regulatory compliance. Choosing the wrong strategy can cause excessive delays, failed submissions, and thousands of dollars in re-designs or testing.

Biorep’s team of regulatory experts has the savvy to avoid typical regulatory failures. We will tailor a plan to suit your needs and budget to ensure regulatory submissions don’t hinder your product success. We will manage that plan through the end, ensuring you have the needed support to tackle tough submission questions or audits.

Since the regulatory landscape is constantly changing, our team stays is ready to meet your needs. Whether it’s updating your device or process to a new standard or responding to regulatory observations or waring letters, you can count on our team to partner with you to ensure success.