{"id":7518,"date":"2024-04-18T03:09:22","date_gmt":"2024-04-18T03:09:22","guid":{"rendered":"https:\/\/eisnersafety.com\/?p=7518"},"modified":"2024-04-18T03:09:23","modified_gmt":"2024-04-18T03:09:23","slug":"standards-explosion-and-challenges-maintaining-updating%ef%bf%bc","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2024\/04\/18\/standards-explosion-and-challenges-maintaining-updating%ef%bf%bc\/","title":{"rendered":"Standards: Explosion and Challenges Maintaining\/Updating\ufffc"},"content":{"rendered":"\n
\"\"<\/a><\/figure>\n\n\n\n

 My conversation with <\/a>Subhi Saadeh<\/a> of Combinate Podcast<\/a> was very intriguing and he does a fun podcast. Check out the podcast<\/a> as I talk about Standards.<\/p>\n\n\n\n

We covered a lot of ground in a short time (it flew by for me – I’m sure it will for you too) and if you compare him to an architect he would build something similar to the Louvre Museum with its very unique but beautiful peaks and valleys with surprises around every corner. The Lourve is recent in my mind as I was at an ISO TC 210 standards meeting in Paris Dec ’23<\/a> and visited the Louvre. One of my many travels around the world in support of standards development over the last 20 years.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

He really does his research. He found my old reconnaissance standards database I was planning to publish but never did. That was a total surprise. <\/p>\n\n\n\n

We dive right into standards in many ways that you may not have thought of before in Podcast<\/a> :
\u261e The explosion of standards vs no standards (or chaos of no standards)
\u261e The impact of standards on medical device development
\u261e Standards and Regulatory Challenges
\u261e My Notified Body Auditing Experience, Authorization Process, Product Reviewer
\u261e The Challenges of Maintaining and Updating Standards<\/p>\n\n\n\n

Need help with 60601 series standards (Medical Electrical Equipment) including EMC; strategic compliance planning for your medical electrical product lines; need support when FDA or a regulator asks questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner<\/a> is an expert on standards development and sits on many standards committees<\/a>. He also has experts on additional standards committees and we all talk to the regulators. He has a team of experts to support your needs. <\/p>\n\n\n\n

We work with many test labs for Medical Safety & EMC and can arrange other testing, as well. Please let us know if we can help when you contact us.<\/p>\n\n\n\n

Feel free to schedule a call with Leo<\/a> or contact Leo at Leo@EisnerSafety.com or through our contact form<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Standards: Explosion and Challenges Maintaining\/Updating<\/p>\n

\u00a0My conversation with Subhi Saadeh of Combinate Podcast was very intriguing and he does a fun podcast. Check out the Combinate podcast #132 as I, Leo Eisner, talk about Standards.<\/p>\n","protected":false},"author":4,"featured_media":7520,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1433,1402,1425,1517,1386,1325,1510,1397,1398,1403,1440,1514,1516,1371,1520,1443,1493,1445,1410,1365,1344,1389,1367,1394,1501,1519,1424,1518,1439,1515,1396,1370,1461,1369,1381,1523,1347,1431,1522,1521,1498,1444,1435,1391,1492],"tags":[],"class_list":["post-7518","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-1433","category-1402","category-15223-1","category-1517","category-60601-series","category-60601-1","category-60601-1-4th-edition","category-1397","category-1398","category-62366-1","category-active-implants","category-ai","category-apr-2024","category-auditing","category-combination-device","category-combination-product","category-cybersecurity","category-device","category-essential-performance","category-eu","category-fda","category-guidance-documents","category-harmonized-standards","category-iec","category-iec-60601-1","category-iso-13485","category-iso-15223-1","category-iso-20417","category-ivd","category-machine-learning","category-mdd","category-mdr","category-medical-device","category-medical-device-regulation","category-notified-bodies","category-quality-assurance","category-recognized-consensus-standards","category-regulation","category-regulatory-affairs","category-risk-management","category-samd","category-software","category-standards","category-standards-development","category-us"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7518","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=7518"}],"version-history":[{"count":9,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7518\/revisions"}],"predecessor-version":[{"id":7530,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/7518\/revisions\/7530"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media\/7520"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=7518"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=7518"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=7518"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}