Patient safety is at the heart of every successful medical device development. From conceptualization to market launch, ensuring that devices meet stringent safety and performance standards is essential to protect lives and build trust in the healthcare community.
At Bioskills of the North East (BONE) in Fall River, MA, we provide FDA-approved testing labs equipped to support medical device companies through every stage of development. Our 20,000 sq. ft state-of-the-art facility and expert team offer the resources you need to meet regulatory requirements, enhance patient safety, and bring innovative products to market with confidence. Schedule a consultation with us today to see how BONE can streamline your development process.
Partnering with a reliable FDA-approved lab is the foundation for creating devices that truly make a difference.
Ensuring Compliance with Regulatory Standards
Compliance with FDA regulations is non-negotiable when producing safe, effective medical devices. Our FDA-approved testing labs evaluate devices based on critical criteria, including FDA guidelines, medical device ISO standards, and clinical laboratory improvement amendments (CLIA). These evaluations ensure all regulatory safety and effectiveness requirements are met.
BONE stands out with our fully-equipped, in-house FDA testing labs integrated into your development process. Rigorous testing is conducted under FDA oversight, ensuring medical devices comply with federal guidelines and essential testing protocols.
Enhancing Patient Safety
Every medical device must perform reliably in both routine and high-stakes scenarios. FDA-approved labs like ours assess devices using robust methodologies to address risks identified during clinical trials. By simulating realistic conditions, we ensure that devices not only enhance lives but also minimize risks to patients.
At BONE, we use advanced tools to test for radiological safety, durability, and accuracy. By doing so, we help confirm that every product functions as expected, providing reassurance to both manufacturers and end-users.
Streamlining the Approval Process
The FDA intends to streamline the approval process for devices that meet safety and compliance benchmarks. By working with FDA-approved labs like ours, you can reduce timelines for development and approval without sacrificing quality.
Our quality management system is designed to support you through every stage of the product development process. With access to strategic guidance and advanced testing resources, we help innovators meet compliance with confidence and clarity.
Access to Advanced Testing Tools and Expertise
Our facility, spanning 20,000 sq. ft., is home to cutting-edge technology and expertise. We offer flexible surgical stations, advanced global A/V capabilities, and customizable lab spaces to support your research and development efforts. We’re also equipped for in-house specimen procurement, ensuring even moderate complexity tests or specimens with unique abnormalities are handled effectively.
At BONE, we not only foster creativity but also deliver accurate, consistent testing results to elevate the overall quality of your medical devices.
Building Trust with End-Users and Stakeholders
Trust is everything. Devices tested in FDA-approved labs like ours come with the assurance of meeting the highest standards, providing peace of mind to healthcare providers, patients, and stakeholders. When you work with us, you know your devices are ready for the real world.
Reducing Long-Term Costs and Risks
Working with FDA-approved labs gives us the opportunity to identify and resolve issues early in the development process. By addressing weak points through thorough testing, we help avoid costly recalls or liability concerns down the road. Our precise evaluations ensure proactive risk management, saving both time and significant costs.
Staying Ahead in a Competitive Market
The medical device industry moves fast, and staying competitive means innovating quickly and efficiently. By partnering with a facility like ours, you gain access to resources that help accelerate time-to-market without compromising on quality.
At BONE, we thrive as a global hub for refining medical devices. With features like configurable meeting spaces and concierge services, we make it easy for you to focus on your vision while we support you behind the scenes. Our partnerships with leading innovators ensure we stay at the forefront of shaping the future of healthcare.
Why BONE?
Bioskills of the North East (BONE) offers a state-of-the-art, 20,000 sq. ft. facility purpose-built for innovation, education, and device testing. Our flexible spaces and advanced services meet the evolving needs of our clients.
Facility Features
- Surgical Stations: Our facility includes 24 fully equipped, flexible surgical stations designed to accommodate everything from standard procedures to robotic-assisted techniques.
- Flexible Spaces: Customizable meeting rooms and didactic areas allow you to structure events and training sessions to meet your goals.
- Global A/V Capabilities: Engage with teams onsite or virtually using our high-quality audiovisual systems compatible with platforms like Zoom and Microsoft Teams.
- Specimen Services: We offer a broad selection of anatomical specimens, including those with unique abnormalities, and feature large freezer and refrigeration spaces for secure, long-term specimen storage.
- On-Site Catering: Our modern kitchen facilities and dedicated breakout areas simplify event planning and provide flexible meal options during your time at BONE.
At BONE, we believe collaboration accelerates progress. That’s why we partner with industry leaders such as Axial3D, Northeastern University, Prima CARE, and RIMASYS Group to bring best-in-class resources, training, and expertise to every client. These partnerships reflect our deep commitment to advancing surgical and medical innovation across disciplines.
