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In Rodents</a></li> <li><a href="https://www.compbio.com/subcutaneous-implants-video/">Subcutaneous Implants + Video</a></li> </ul> </li> </ul> </div> </div> </div> <div id="primary" class="content-area medium-9 columns"> <div class="header-title"> <h1 class="entry-title">Biocompatibility and Devices</h1> </div> <main id="main" class="site-main" role="main"> <article id="post-5437" class="post-5437 post type-post status-publish format-standard hentry category-general"> <div id="breadcrumb"> <div id="crumbs"><span class="crumb"><a href="https://www.compbio.com">Home</a></span> <i class="fa fa-angle-right"></i> <span class="crumb"><a href="https://www.compbio.comgeneral/">General</a></span> <i class="fa fa-angle-right"></i> <span class="current">Biocompatibility and Devices</span></div> </div> <div class="entry-content"> <div class="the-content-contain"> <div class="row builder-row content-row"> <div class="medium-12 columns"> <h3><img class="wp-image-5441 alignleft" src="https://www.compbio.com/images/Screen-Shot-2021-12-15-at-2.51.34-PM.png?v=1712953904" alt="" width="1420" height="665" srcset="https://www.compbio.com/images/Screen-Shot-2021-12-15-at-2.51.34-PM.png?v=1712953904 1846w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-2.51.34-PM-300x140.png?v=1712953921 300w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-2.51.34-PM-1024x479.png?v=1712953927 1024w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-2.51.34-PM-768x359.png?v=1712953934 768w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-2.51.34-PM-1536x719.png?v=1712953940 1536w" sizes="(max-width: 1420px) 100vw, 1420px"></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h3></h3> <h2><strong>Biocompatibility and Devices Research</strong></h2> <p>Biocompatibility is the ability of an implant material to function in vivo without eliciting detrimental local or systemic responses in the body. Prior to their use in human fracture fixation, biomaterials undergo<span class="Apple-converted-space"> </span>tissue and animal testing to determine their safety and efficacy.</p> <p>Here at Comparative Biosciences, Inc.<span class="Apple-converted-space"> </span>We offer a range of safety evaluation and biocompatibility services for medical devices.</p> <p><b>CBI’s Biocompatibility Testing Services For Medical Devices</b></p> <p>We take pride in the technical depth, experience and breadth of services we offer, while maintaining our focus on putting our clients’ needs first.<span class="Apple-converted-space">  </span>CBI has the team you can trust to get the job done, regardless of your specific needs, including bringing a new product through research and development, interacting with the Regulators are all part of pre-IND meetings and pre-approval inspections.</p> <p> </p> <p><img loading="lazy" class=" wp-image-5449 alignleft" src="https://www.compbio.com/images/Screen-Shot-2021-12-15-at-3.13.15-PM.png?v=1712953947" alt="" width="1250" height="426" srcset="https://www.compbio.com/images/Screen-Shot-2021-12-15-at-3.13.15-PM.png?v=1712953947 1320w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-3.13.15-PM-300x102.png?v=1712953953 300w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-3.13.15-PM-1024x349.png?v=1712953960 1024w, https://www.compbio.com/images/Screen-Shot-2021-12-15-at-3.13.15-PM-768x262.png?v=1712953968 768w" sizes="(max-width: 1250px) 100vw, 1250px"></p> <h3><strong>Medical Devices Biocompatibility Testing – A Risk-Based Framework for Biocompatibility Assessment</strong></h3> <p><b>What exactly is a “risk-based approach?”<span class="Apple-converted-space"> </span></b></p> <p>ISO 14971 defines the term “risk” as “the combination of the probability of occurrence of harm and the severity of that harm.” The standard defines harm primarily as physical injuries and damage to health, but it also includes harm to goods and to the environment.<span class="Apple-converted-space"> </span></p> <p><b>ISO 14971 is the key to effective risk management for medical devices.</b></p> <p>ISO 14971 is the risk management standard for medical devices. This includes software as a medical device and in vitro diagnostic medical devices. It contains a structured approach for effective risk management. The risk-based approach adds the harm resulting from regulatory non-compliance and bureaucracy. It is about weighing the likelihood and the consequence of the identified risks and adapting the expenditure of<span class="Apple-converted-space"> </span>resources accordingly.<span class="Apple-converted-space"> </span></p> <div class="the-content-contain"> <div class="row builder-row content-row"> <div class="medium-12 columns"> <h3><em>In Vivo</em> Assays</h3> <ul> <li>Acute, systemic, subacute, chronic and carcinogenicity toxicity studies</li> <li>Beuhler, Draize and Magnussen-Kligman maximization testing</li> <li>Biocompatibility</li> <li>Bone, joint,  and orthopedic</li> <li>Contact lens testing, ISO-9394</li> <li>Device-drug combinations</li> <li>Device-stem cell combinations</li> <li>Dermal, ocular, mucosal irritation testing</li> <li>Bone, joint, and orthopedic</li> <li>Long-term surgical implantation studies</li> <li>Muscle, bone, subcutaneous and intradermal implantation</li> <li>Topical, intracutaneous, ocular and primary skin irritation testing</li> <li>Pyrogenicity testing</li> </ul> <p>CBI has conducted numerous studies related to dural, amnionic, pericardial and other patches, coated films, sutures, matrices, osteoinduction materials, cartilage regeneration, morselized bone, spinal fusion, bone regeneration and tendon repair. These studies are often customized or unique experiments.</p> <h3><strong><em>Safety Pharmacology</em></strong><strong> Assays</strong></h3> <ul> <li>Safety Pharmacology: Irwin, respiratory, cardiovascular intravenous irritation, CNS</li> </ul> <p><em>In Vitro</em> Assays</p> <ul> <li>Blood compatibility testing (hemocompatibility)</li> <li>Cytotoxicity testing (Agar overlay and MEM elution)</li> <li>Other <em>in vitro</em> assays</li> <li>ELISA</li> </ul> </div> </div> </div> <p><a href="https://www.compbio.com/files/CBI-Tec-Bulletin-Biocompatibility.pdf?v=1712605602"><img loading="lazy" class="wp-image-5458 alignleft" src="https://www.compbio.com/images/Screen-Shot-2022-01-06-at-1.10.40-PM.png?v=1712954183" alt="" width="398" height="413" srcset="https://www.compbio.com/images/Screen-Shot-2022-01-06-at-1.10.40-PM.png?v=1712954183 1152w, https://www.compbio.com/images/Screen-Shot-2022-01-06-at-1.10.40-PM-289x300.png?v=1712954198 289w, https://www.compbio.com/images/Screen-Shot-2022-01-06-at-1.10.40-PM-986x1024.png?v=1712954205 986w, https://www.compbio.com/images/Screen-Shot-2022-01-06-at-1.10.40-PM-768x797.png?v=1712954211 768w" sizes="(max-width: 398px) 100vw, 398px"></a></p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p><a href="https://www.compbio.com/files/CBI-Tec-Bulletin-Biocompatibility.pdf?v=1712605602"><strong>CHECK OUT OUR BIOCOMPATIBILITY AND DEVICES  .  PDF FILE</strong></a></p> <p> </p> <div class="the-content-contain"> <div class="row builder-row content-row"> <div class="medium-12 columns"> <p>Have any additional questions? <a href="https://www.compbio.com/contact-us/">Contact us</a> today!</p> </div> </div> </div> <div class="bottom-cta center"></div> <p> </p> </div> </div> </div> </div> </article> </main> </div> </div> <div class="call-out"> <h3 class="content-left"><span class="line-one">Have a question</span> <span class="line-two">or need a quote?</span></h3> <svg version="1.1" id="Layer_1" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" x="0px" y="0px" viewBox="0 0 100 85" style="enable-background:new 0 0 100 85;" xml:space="preserve"> <style type="text/css"> .st0{fill:#FFFFFF;} </style> <g> <path class="st0" d="M64.3,0.5H16c-8.8,0-16,7.2-16,16V44c0,8.4,6.6,15.4,14.9,16l-3.7,17.4L31.6,60h8.8V43.9 c0-8.7,7.1-15.8,15.8-15.8h24.2V16.5C80.3,7.7,73.1,0.5,64.3,0.5z"/> <path class="st0" d="M89.1,33h-33c-6,0-10.9,4.9-10.9,10.9v18.8c0,6,4.9,10.9,10.9,10.9h22.4l13.9,11.8l-2.5-11.9 c5.7-0.4,10.2-5.1,10.2-10.9V44C100,38,95.1,33,89.1,33z M85.5,49.3c2.2,0,4,1.8,4,4.1c0,2.2-1.8,4.1-4,4.1s-4-1.8-4-4.1 C81.5,51.1,83.3,49.3,85.5,49.3z M59.6,57.4c-2.2,0-4-1.8-4-4.1c0-2.2,1.8-4.1,4-4.1c2.2,0,4,1.8,4,4.1 C63.7,55.6,61.9,57.4,59.6,57.4z M68.5,53.4c0-2.2,1.8-4.1,4-4.1s4,1.8,4,4.1c0,2.2-1.8,4.1-4,4.1S68.5,55.6,68.5,53.4z"/> </g> </svg> <h3 class="content-right"><span>We can help!</span> <a href="https://www.compbio.com/contact-us/"><span class="cta-btn">Contact us</span></a></h3> </div> </div> </div> <footer id="colophon" class="site-footer row"> <div class="site-info medium-12 columns"> Comparative Biosciences, Inc. · <strong>Phone: 888-994-4879</strong><br> Copyright 2024 Comparative Biosciences, Inc. 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