Leo Eisner, The60601Guy will be visiting London in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.

Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, 𝗯𝗼𝗼𝗸 𝗻𝗼𝘄 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁. I’d love to chat!

Let’s connect, and explore how we can support your company with our international team of compliance & regulatory experts from Eisner Safety Consultants. I’m eager to learn what you’re working on and how you’re driving change and innovation in the industry, and how we can support you to get you to market faster.

Let’s meet up! 𝗕𝗼𝗼𝗸 𝘁𝗶𝗺𝗲 𝗼𝗻 𝗺𝘆 𝘀𝗽𝗲𝗰𝗶𝗮𝗹 𝗰𝗮𝗹𝗲𝗻𝗱𝗮𝗿 for 𝗺𝘆 𝗟𝗼𝗻𝗱𝗼𝗻 𝘃𝗶𝘀𝗶𝘁.

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

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 and visited the Louvre. One of my many travels around the world in support of standards development over the last 20 years.

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.

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

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 is an expert on standards development and sits on many standards committees. 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.

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.

Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.

Q4’ 2027: Article 123 (3) (d) MDR/113 (3) (f) IVDR

• Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),
• Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),
• MSU (Evaluation of devices on the market by Competent Authorities),
• Vigilance (& Post Market Surveillance), and
• CI/PS (Before a device is placed on the market – Clinical Investigation and Performance Study)

Q2’ 2029: Article 123 (3) (e) MDR/113 (3) (a) IVDR

• Devices (Based on UDIs registered in EUDAMED) and
• Certificates (see above)

* For a brief explanation of EUDAMED modules refer to the below

Need help with Medical Electrical Equipment standards (60601/80601 series) including Safety/EMC; strategic 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 is an expert on standards development and sits on many standards committees. 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. Feel free to schedule a call with Leo or contact Leo at Leo@EisnerSafety.com or through our contact form.

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

Are you falling behind on your internal audit or supplier audit plans due to COVID-19, other emergency situations, sickness, travel restrictions, time constraints?  It really doesn’t matter the reason why you can rely on external resources to support your audits plans for internal and supplier audits to keep your QMS on track.

Some items to consider for a remote audit that we like to discuss with our clients up front:

• Are you able to access RA/QA documents & records if you are working from home?
• Are your RA/QA documents & records maintained digitally or can they be pdf’ed?
• Are you able to share RA/QA documents & records during the remote audit live (scroll through on-screen) or share them thru tools like DropBox, Google Drive, or similar so the auditor(s) can review during the audit?
• How do you guarantee the documents you share with the audit team are returned or destroyed?
• What are your confidentiality policies and how will that limit your ability to share documents? 
• What about if your auditor is a foreign national and you have national security requirements you need to follow?
• Coordination of a test run of the selected technology to use for the remote audit to make sure work through issues upfront and deal with bandwidth, contingency planning, live document review, & document sharing.
• This list is going to vary depending on your specific circumstances so have an honest discussion with the auditor upfront and during audit planning to make sure the appropriate preparations and contingency plans are considered.

ISO 19011:2018 allows for remote auditing with the use of technology such as Webex, Zoom, Skype, or other video conferencing services along with document sharing services such as DropBox, Google Drive, Box, and more.  The goal of the remote or the on-site audit is the same to verify objective evidence.

Your auditor should be flexible to work with you for what tech works best for your organization.  Work with the auditor to determine ground rules upfront and ask your auditor to review the following checklist of items well before the audit:

• Audit Plan:  Ask your auditor for an audit plan at least several weeks in advance so you can arrange personnel off-site & on-site.  Will all personnel in the audit be on the same time zone and do you need break out room(s) for multiple auditors?  Ask the lead auditor to list what generic documents they always request for all audits so you can have prepared
  • Quality Manual
  • List/index of all QMS procedures/work instructions
  • Management Review procedure
  • Complaint handling procedure
  • List of complaints since the last audit
  • CAPA procedure
  • List of CAPA open/close since the last audit
  • Internal audit schedule
• Sampling Records:  The auditor will need to sample records like in any on-site audit, so query them how this will be done, which types of records will be needed, and in what format the records should be (example: screenshots of folders showing record files, live shots of records, discuss what works for your existing tech).    
• Sharing of Files:  You should request the auditor be flexible enough to use the technology that works best for your organization unless the auditor is physically unable to use the specific technology.
• Contingency Planning:  What happens if an auditor or auditee gets disconnected or if there are some technical issues?  Come to an agreement on what should be done.
• Agreement of Confidentiality:  How will the documents you share with the auditor be accessed, saved, and discarded after the audit.  See the fourth bullet in the above section.
• Break Times:  An 8-hour remote audit is a long workday and maybe too long of a workday.  When doing a couple of remote audits of more than 2 days long it was noted that it is beneficial for all to shorten the remote audit days to less than 7 hours of audit time.  Also, it is critical to agree on break times including lunch breaks, short stretch breaks, and if other breaks may be needed.
• Test run:  Conduct a test run with the auditor(s) and your team (at least some on-site & off-site members) to test-drive the technology about a week prior to the audit to ensure there are no issues with internet, audio, video, document viewing/displaying, transfer of documents, sharing of files, browser compatibility, headsets, contingency planning, etc.            
• Opening & Closing Meetings:  Will you have all your personnel in one place, or will they be scattered off-site and on-site? If you need to pull together your personnel using an online platform such as Webex, Zoom, or similar.  You’ll want to do a short 5 – 10 minute test run to make sure everyone can call in an make the technology works.  You may want to test it with the auditor to make sure all parties are able to make it work.

This is the time for you to review your internal audit and supplier audit schedules.  We are able to support these with a remote audit to help you keep on track and on schedule.

Feel free to contact us to discuss your needs. Contact Leo Eisner to help you thru this process by scheduling a call with Leo.