{"id":4976,"date":"2026-05-27T09:46:45","date_gmt":"2026-05-27T09:46:45","guid":{"rendered":"https:\/\/flj-pcb.com\/?page_id=4976"},"modified":"2026-05-27T09:46:47","modified_gmt":"2026-05-27T09:46:47","slug":"medical-pcb-guide","status":"publish","type":"page","link":"https:\/\/flj-pcb.com\/fa\/medical-pcb-guide\/","title":{"rendered":"Medical PCB Manufacturing Guide: Class 3, ISO 13485 &amp; DFM"},"content":{"rendered":"<p>Medical PCBs are the nervous system of modern healthcare. They live inside pacemakers, imaging machines, patient monitors, and robotic surgery tools. A single board failure can risk a life. So every medical PCB demands zero-defect manufacturing, full traceability, and strict adherence to standards our factory has mastered over 15 years.<\/p>\n\n\n\n<p>We do not just talk about reliability. We build boards that meet <a href=\"https:\/\/resources.altium.com\/p\/meeting-standards-ipc-6012-class-3-annular-ring\" target=\"_blank\" rel=\"noopener\">IPC\u20116012 Class\u202f3<\/a>, support IEC\u202f60601\u20111 clearance rules, and come with an ISO\u202f13485\u2011audited quality system. In this article, you will learn how to design, specify, and source a medical PCB that passes regulatory scrutiny \u2014 and how to avoid the hidden pitfalls that generic PCB shops never mention. We will also break down real medical PCB costs, lead times for Class\u202f3 quick\u2011turn, and the DFM rules that prevent field failures.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Medical PCB Applications and Types<\/h2>\n\n\n\n<p>Medical devices push PCB technology to its limits. A hearing aid needs a flexible circuit so thin it can fold into an ear canal. An MRI coil requires dielectric materials with zero magnetic signature. A CT scanner processor board may carry hundreds of high\u2011speed signals on 20+ layers. Below are the most common PCB types you will specify.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"530\" height=\"347\" src=\"https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB.webp\" alt=\"Medical PCB\" class=\"wp-image-4978\" srcset=\"https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB.webp 530w, https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB-300x196.webp 300w, https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB-18x12.webp 18w\" sizes=\"(max-width: 530px) 100vw, 530px\" \/><\/figure>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>High\u2011Density Interconnect (HDI) Medical PCBs<\/strong><br>When space is the scarcest resource, HDI packs more connections into less area. We build HDI boards with laser\u2011drilled microvias down to 75\u202f\u00b5m, multiple build\u2011up layers, and via\u2011in\u2011pad structures. Use HDI for handheld ultrasound probes, capsule endoscopes, or implanted neurostimulators where every millimeter matters.<\/li>\n\n\n\n<li><strong>Flex and Rigid\u2011Flex Medical PCBs<\/strong><br>Devices that bend, twist, or must survive millions of dynamic cycles need flex circuits. A wearable glucose monitor contains a polyimide flex that wraps around a wrist while routing 0.10\u202fmm traces. Rigid\u2011flex eliminates connectors \u2014 a major source of failure in body\u2011worn electronics. Our factory laminates polyimide flex layers with FR\u20114 rigid sections, then fills transition vias with non\u2011conductive epoxy for structural integrity.<\/li>\n\n\n\n<li><strong>Rigid PCBs for Hospital Equipment<\/strong><br>Large\u2011format rigid boards for X\u2011ray detectors, ventilators, and lab analyzers often run on standard FR\u20114 with high copper weight (2\u202foz or 3\u202foz) for thermal management. We can produce up to 32\u2011layer rigid medical PCBs with controlled impedance, blind\/buried vias, and ENIG surface finish.<\/li>\n<\/ul>\n\n\n\n<p>No matter the type, the board must match the electrical, thermal, and mechanical demands of the application. Next, we detail the mandatory compliance framework.<\/p>\n\n\n\n<div class=\"wp-block-buttons spectra-popup-trigger-4901 is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-78682768 wp-block-buttons-is-layout-flex\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--20);padding-bottom:var(--wp--preset--spacing--20)\">\n<div class=\"wp-block-button has-custom-width wp-block-button__width-50\"><a class=\"wp-block-button__link wp-element-button\">Get Medical PCB Quote<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Key Compliances for Medical PCBs<\/h2>\n\n\n\n<p>A PCB is just a component of a medical device. But the fabrication process itself must demonstrate control and repeatability. These are the standards our factory lives by.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ISO\u202f13485:2016 Quality Management<\/h3>\n\n\n\n<p>ISO\u202f13485 is not a PCB standard; it is a quality\u2011system certificate specific to medical device components. Our facility holds ISO\u202f13485 certification with a scope that explicitly covers PCB fabrication. An annual surveillance audit verifies document control, traceability of raw materials, and process validation (IQ\/OQ\/PQ). For you, that means every production lot comes with a Device History Record (DHR) \u2014 a complete paper trail from laminate batch to final electrical test.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">IPC\u20116012 Class\u202f3 and IPC\u2011A\u2011600 Inspection<\/h3>\n\n\n\n<p>Class\u202f3 is the highest reliability grade for PCBs. It demands:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Minimum annular ring of 0.125\u202fmm on drilled holes.<\/li>\n\n\n\n<li>No lifted lands, nicks deeper than 20% of conductor width, or plating voids.<\/li>\n\n\n\n<li>100% micro\u2011section analysis per lot \u2014 we cut two cross\u2011sections per panel to measure copper thickness in holes (minimum 20\u202f\u00b5m) and check for inner\u2011layer separation.<\/li>\n<\/ul>\n\n\n\n<p>We inspect finished boards to IPC\u2011A\u2011600 Class\u202f3 acceptance criteria using 2D\/3D AOI with comparison to the original Gerber data. Any board with a mismatch goes to manual review. We also perform 4\u2011wire Kelvin netlist testing to catch opens and shorts that visual inspection misses.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">IEC\u202f60601\u20111 and Creepage\/Clearance<\/h3>\n\n\n\n<p>The medical safety standard IEC\u202f60601\u20111 defines minimum creepage and clearance distances to prevent electric shock. A PCB shop cannot \u201ccertify\u201d a bare board to IEC\u202f60601\u20111; that is your device\u2011level responsibility. But we can build to any creepage value you specify \u2014 and we verify it with automated optical measurement reports. For high\u2011voltage isolation (above 250\u202fV), we also enforce design rules that prevent conductive anodic filament (CAF) formation, which we cover in the DFM section.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">FDA Registration<\/h3>\n\n\n\n<p><a href=\"https:\/\/flj-pcb.com\/fa\/about\/\" data-type=\"page\" data-id=\"1575\">\u06a9\u0627\u0631\u062e\u0627\u0646\u0647 \u0645\u0627<\/a> is FDA\u2011registered as a contract manufacturer. That does not replace your device listing, but it means we operate under a quality system recognized by the FDA. If you need a supplier who can provide full traceability for a 510(k) or PMA submission, we meet that requirement.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Choosing Materials for Medical PCBs<\/h2>\n\n\n\n<p>Material selection drives both performance and compliance. A poorly chosen laminate can lead to CAF growth between biased traces, delamination during autoclave sterilization, or signal integrity loss in high\u2011speed imaging.<\/p>\n\n\n\n<p>Below is a comparison of the materials we use most often for medical applications.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u0645\u0648\u0627\u062f<\/th><th>Tg (\u00b0C)<\/th><th>CTI (V)<\/th><th>Dk @1\u202fGHz<\/th><th>Water Absorption (%)<\/th><th>Z\u2011axis CTE (ppm\/\u00b0C)<\/th><th>Typical Medical Use<\/th><\/tr><\/thead><tbody><tr><td>Standard FR\u20114 (Tg\u202f150)<\/td><td>150<\/td><td>175\u2013250<\/td><td>4.2\u20134.5<\/td><td>0.15<\/td><td>50\u201370<\/td><td>Non\u2011critical monitoring, lab equipment<\/td><\/tr><tr><td>High\u2011Tg FR\u20114 (Tg\u202f170)<\/td><td>170<\/td><td>200\u2013300<\/td><td>4.0\u20134.3<\/td><td>0.12<\/td><td>35\u201345<\/td><td>High\u2011layer\u2011count imaging, ventilators<\/td><\/tr><tr><td>Isola 370HR<\/td><td>180<\/td><td>400+<\/td><td>3.9<\/td><td>0.10<\/td><td>35<\/td><td>High\u2011voltage isolation, defibrillator circuits<\/td><\/tr><tr><td>Polyimide (flex)<\/td><td>250<\/td><td>300\u2013600*<\/td><td>3.4\u20133.6<\/td><td>1.0\u20132.0**<\/td><td>40\u201360 (film)<\/td><td>Wearables, flexible probes, dynamic flexing<\/td><\/tr><tr><td>Rogers 4350B<\/td><td>&gt;280<\/td><td>165<\/td><td>3.48<\/td><td>0.06<\/td><td>32 (X\/Y)<\/td><td>RF coils for MRI, wireless patient telemetry<\/td><\/tr><tr><td>Liquid Crystal Polymer (LCP)<\/td><td>280<\/td><td>&gt;500<\/td><td>2.9\u20133.2<\/td><td>&lt;0.02<\/td><td>17\u201330<\/td><td>Implantable flex with long\u2011term body\u2011fluid resistance<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>CTI of polyimide depends on the specific laminate grade; consult the supplier data sheet.<br>Polyimide absorbs moisture; for implantables that must remain dry, LCP is superior.<\/p>\n\n\n\n<div class=\"wp-block-buttons spectra-popup-trigger-4901 is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-78682768 wp-block-buttons-is-layout-flex\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--20);padding-bottom:var(--wp--preset--spacing--20)\">\n<div class=\"wp-block-button has-custom-width wp-block-button__width-50\"><a class=\"wp-block-button__link wp-element-button\">Get Medical PCB Quote<\/a><\/div>\n<\/div>\n\n\n\n<p>For most Class\u202f3 designs, we recommend high\u2011Tg <a href=\"https:\/\/flj-pcb.com\/fa\/fr-4-pcb-guide-properties-limits-material-choices\/\" data-type=\"post\" data-id=\"4641\">FR-4<\/a> like Isola 370HR because its CTI above 400\u202fV allows smaller creepage distances. When the device contacts the patient directly, we often switch to Rogers or LCP to avoid CAF under humid or ion\u2011rich conditions. Our engineering team can help you pick the right material for your stackup and reliability budget.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">DFM Checklist for High\u2011Reliability Medical PCBs<\/h2>\n\n\n\n<p>Design\u2011for\u2011manufacturability (DFM) prevents failures before the first board is built. These rules come from failure analysis of real medical devices.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Creepage and Solder Mask Dam Width.<\/strong><br>Meeting bare\u2011copper creepage per IEC\u202f60601\u20111 is not enough. In a humid environment, moisture can form a conductive path across the solder mask surface. We enforce a minimum mask dam of 0.20\u202fmm between high\u2011voltage traces on the same layer. This barrier blocks ion migration and reduces the risk of CAF.<\/li>\n\n\n\n<li><strong>Inner\u2011Layer Pad Anti\u2011Pad Clearance for Flex.<\/strong><br>When laser drilling microvias through a polyimide flex layer, the drill can drag copper slivers from the inner pad if the anti\u2011pad gap is too small. Set the clearance to at least 0.30\u202fmm to avoid slivering and subsequent short circuits.<\/li>\n\n\n\n<li><strong>Via\u2011in\u2011Pad Restrictions for Dynamic Flex.<\/strong><br>Avoid placing via\u2011in\u2011pad on a flex circuit that will bend repeatedly. The stress concentration around the via can crack the barrel. If you must use via\u2011in\u2011pad for density, specify non\u2011conductive epoxy fill and cap with ENIG to create a flat surface.<\/li>\n\n\n\n<li><strong>Copper Weight for Heat Spreading.<\/strong><br>In an active implant like a neurostimulator, the PCB must dissipate heat from a small area without fans or vents. Increase the copper weight on inner power planes to 2\u202foz or more. This thermal mass spreads heat laterally and reduces hot\u2011spot temperature.<\/li>\n\n\n\n<li><strong>Controlled Impedance with Tight Tolerance.<\/strong><br>Many medical imaging and RF ablation systems require \u00b17% or \u00b15% impedance control on differential pairs. Our factory calculates the stackup using the actual Dk value of the laminate (not just the supplier\u2019s nominal) and adjusts line width accordingly. We verify every impedance coupon with TDR and include the test report in the DHR.<\/li>\n<\/ul>\n\n\n\n<p>Putting these rules into your design reduces NRE cycles and ensures the PCB passes IPC Class\u202f3 inspection on the first build.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Medical PCB Cost Breakdown: From Prototype to Production<\/h2>\n\n\n\n<p>Medical PCB pricing is not a mystery. It follows a clear formula, and understanding it helps you budget and negotiate.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img decoding=\"async\" width=\"640\" height=\"427\" src=\"https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB-Cost-Breakdown.webp\" alt=\"Medical PCB Cost Breakdown\" class=\"wp-image-4977\" srcset=\"https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB-Cost-Breakdown.webp 640w, https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB-Cost-Breakdown-300x200.webp 300w, https:\/\/flj-pcb.com\/wp-content\/uploads\/2026\/05\/Medical-PCB-Cost-Breakdown-18x12.webp 18w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/figure>\n\n\n\n<p>Four factors dominate the medical PCB price:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>IPC Class.<\/strong><br>Class\u202f3 adds roughly 18\u201322% to the fabrication cost versus Class\u202f2. The increase covers extra inspection steps (100% AOI, mandatory micro\u2011sectioning, tighter drill registration) and the higher scrap rate from rejecting boards that would pass Class\u202f2 criteria.<\/li>\n\n\n\n<li><strong>Layer Count and Thickness.<\/strong><br>A 4\u2011layer Class\u202f3 board with a 1.6\u202fmm overall thickness costs less than an 8\u2011layer board of the same size. Each additional layer pair adds lamination, drilling, and plating cycles.<\/li>\n\n\n\n<li><strong>Surface Finish.<\/strong><br>ENIG (electroless nickel immersion gold) is the most common medical finish because it provides a flat, solderable surface with good shelf life. Immersion silver offers better high\u2011frequency performance but must be soldered within a shorter window. ENIG typically adds 12\u201315% to the board cost versus HASL (which we do not use for medical). For implantable contacts, hard gold plating over nickel is required to withstand body\u2011fluid corrosion \u2014 that process adds a premium.<\/li>\n\n\n\n<li><strong>Quantity and Panel Utilization.<\/strong><br>Prototype quantities (10\u201350 pieces) have high NRE charges and low panel efficiency. At 500 units, we can gang multiple boards on a panel to amortize tooling costs. Our factory does not have a fixed MOQ for medical PCBs; we produce as few as 5 panels for prototype runs. However, lower quantities drive up the per\u2011unit cost.<\/li>\n<\/ol>\n\n\n\n<p><strong>Example cost range<\/strong>&nbsp;(4\u2011layer, 100\u00d7150\u202fmm, ENIG finish, Class\u202f3, FR\u20114 Tg\u202f170, standard lead time):<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>10\u202fpcs: $45\u201360\/unit<\/li>\n\n\n\n<li>500\u202fpcs: $12\u201318\/unit<\/li>\n\n\n\n<li>2,000\u202fpcs: $7\u201310\/unit<\/li>\n<\/ul>\n\n\n\n<p>These are estimates. We provide a fixed\u2011price quote after reviewing your Gerber files and stackup requirements.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Medical PCB Lead Times \u2013 What to Expect<\/h2>\n\n\n\n<p>\u201cQuick\u2011turn Class\u202f3\u201d does not mean 24 hours. A true Class\u202f3 medical PCB requires time for multiple quality gates.<\/p>\n\n\n\n<p>Our standard lead time for a 4\u2011layer Class\u202f3 board is&nbsp;<strong>8\u201310 working days<\/strong>. An 8\u2011layer board might take 12\u201315 days. The extra time is needed for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Two micro\u2011section coupons per fabrication panel (cross\u2011sectioning, mounting, polishing, and measurement).<\/li>\n\n\n\n<li>100% electrical test using flying probe or fixture, depending on quantity.<\/li>\n\n\n\n<li>Final AOI and visual inspection to IPC\u2011A\u2011600 Class\u202f3.<\/li>\n<\/ul>\n\n\n\n<p>We do offer&nbsp;<strong>expedited 5\u2011day service<\/strong>&nbsp;on 4\u2011layer boards if you accept a risk waiver to reduce micro\u2011section sampling to one coupon. We do not recommend this for implantable or life\u2011sustaining devices, because a latent plating void might only appear after thermal cycling. For critical projects, always choose the standard lead time with full lot verification.<\/p>\n\n\n\n<p>Our factory communicates the delivery schedule at the quote stage, and we ship on time. If your project needs a faster spin, ask our engineers about available capacity \u2014 we can sometimes fit a rush order without compromising test coverage.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">How to Audit a Medical PCB Supplier<\/h2>\n\n\n\n<p>A valid ISO\u202f13485 certificate is just the starting point. When you evaluate a PCB partner, dig deeper.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Scope of Certification.<\/strong><br>Confirm the ISO\u202f13485 certificate explicitly covers PCB fabrication, not just assembly or contract manufacturing. Ask for the latest audit report summary to see any non\u2011conformities and their resolution.<\/li>\n\n\n\n<li><strong>FDA Registration Status.<\/strong><br>Being FDA\u2011registered means the facility is listed as a contract manufacturer and follows Good Manufacturing Practices (GMP). Request the FDA establishment registration number and verify it on the FDA website. This registration supports your own device submission because it demonstrates a controlled supply chain.<\/li>\n\n\n\n<li><strong>Process Validation Records.<\/strong><br>Critical processes like ENIG plating, microvia formation, and lamination must have IQ\/OQ\/PQ documentation. Ask to see the protocol for plating thickness control, including SPC charts. A supplier that cannot show validated processes will not pass a rigorous regulatory audit.<\/li>\n\n\n\n<li><strong>In\u2011House Test Capabilities.<\/strong><br>The best medical PCB suppliers perform all testing internally \u2014 no subcontracting. We have flying probe testers, TDR for impedance, micro\u2011section lab, and ionic contamination testers in\u2011house. This single\u2011site control eliminates communication gaps and keeps your data secure.<\/li>\n\n\n\n<li><strong>Traceability.<\/strong><br>For every order, you should receive a DHR containing the certificate of conformance, material lot numbers, first\u2011article inspection report, copper plating thickness data, AOI reports, electrical test results, and ionic cleanliness report. If the supplier hesitates to provide all of these, consider it a red flag.<\/li>\n<\/ul>\n\n\n\n<p>We encourage on\u2011site audits. You can walk through our class\u201110,000 cleanroom and see exactly how we build your boards. That transparency is what full medical PCB supplier qualification demands.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u0633\u0648\u0627\u0644\u0627\u062a \u0645\u062a\u062f\u0627\u0648\u0644<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">What is the minimum order quantity for medical PCBs?<\/h3>\n\n\n\n<p>We do not enforce a hard MOQ. We build as few as 5 prototype panels for medical PCB validation. However, single\u2011piece or very small runs carry a higher unit cost due to NRE and panel setup charges.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">How do you ensure impedance control on medical PCBs?<\/h3>\n\n\n\n<p>We calculate the stackup using the laminate\u2019s measured dielectric constant, adjust trace geometry, and place an impedance coupon on every panel. We test each coupon with a TDR and include the results in the DHR. Tolerances of \u00b17% are standard; \u00b15% is available on request.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Do you provide ENIG surface finish for medical applications?<\/h3>\n\n\n\n<p>Yes, ENIG is our default medical finish. We plate 3\u20135\u202f\u00b5m of nickel and 0.05\u20130.10\u202f\u00b5m of immersion gold per IPC\u20114552. For implantable contacts that require repeated mating, we offer hard gold plating over nickel.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What is the difference between ISO\u202f13485 and IPC\u20116012?<\/h3>\n\n\n\n<p>ISO\u202f13485 is a quality management standard for medical device components. IPC\u20116012 is a performance specification for rigid PCBs. We hold both: our ISO\u202f13485 system ensures process control, and our boards are built and inspected to IPC\u20116012 Class\u202f3.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">How quickly can I get a Class\u202f3 medical PCB prototype?<\/h3>\n\n\n\n<p>Our 5\u2011day expedited service is available for 4\u2011layer designs with a risk\u2011acknowledgement waiver on one micro\u2011section. For full Class\u202f3 lot verification, standard lead time is 8\u201310 working days.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Do you support rigid\u2011flex medical PCB designs?<\/h3>\n\n\n\n<p>Absolutely. We laminate rigid FR\u20114 sections to polyimide flex layers, fill transition vias with non\u2011conductive epoxy, and apply coverlay or liquid photo\u2011imageable solder mask as needed. We also build LCP\u2011based rigid\u2011flex for body\u2011fluid resistant implants.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Can you help with DFM for a wearable medical device?<\/h3>\n\n\n\n<p>Our engineers review every design for creepage, CAF risk, via\u2011in\u2011pad stress, and impedance. We provide a detailed DFM report with suggested changes before production starts. This service is free with every order.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What documentation comes with the shipment?<\/h3>\n\n\n\n<p>You receive a Device History Record containing certificate of conformance, material specifications, first\u2011article inspection report, reflow profile copy (if assembly is included), AOI\/visual inspection report, electrical test report, ionic cleanliness result, and any micro\u2011section analysis images. This supports your regulatory file.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Get Your Medical PCBs Built with Full Traceability<\/h2>\n\n\n\n<p>A medical device is only as reliable as the PCB at its core. Do not leave that reliability to chance. We combine ISO\u202f13485\u2011certified processes, IPC Class\u202f3 manufacturing, FDA registration, and 15 years of factory\u2011floor experience into every board we ship. 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