6 min reading time

“I find many device manufacturers fall short with their documentation,” writes CEO Emanuel Weisgras, who answered my group invitation with expertise to share here.

He writes,

These five points may help you through regulatory and speed you to market.

1. Have an outside technical writer prepare your Instructions for Use (IFU). The IFU must be written so someone completely unfamiliar with the device can know how to use it. An independent technical writer who picks up the device, learns how to use it, and writes about it is the way to go.

2. Remember American English (for FDA) is different than UK English (for CE Marks). Having both on one submission is just plain sloppy and may introduce confusion and delay.

3. Define your terminology and use it consistently. Doing so will be enormously helpful when you’re translating for different markets. Create a term list and style sheet to ensure your documentation is consistent and professional.

4. Validate your documents for completeness. Submissions and the like go into a bureaucratic vortex. Don’t make it harder for them to get through your work.

5. When translating, exclusively use a provider who:
• knows medical device market requirements
• uses specialized and experienced linguists
• uses a second translator to check for accuracy and consistency
• provides a detailed certificate of accuracy to make sure a professional did the work.”

Thank you, Emanuel. Learn more at http://weistrans.com.

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If you read this and thought, “I have something Joe could share in a future announcement,” contact me because:
• 350,000 heads are better than one.
• You know stuff I don’t.
• You get free exposure to 350,000 group members.

Everybody wins.

Email me at JHage@MedicalDevicesGroup.net with suggestions, thanks.

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April 29: Startup Pitch tank at World Health Congress in DC. 100 applications considered, 30 pitch: Code HPIO2018 saves $100.

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Great, thoughtful comments and I’m especially heartened by the fact this post was materially written by a group member.

I’m not sure how best to emphasize: This is Our Group, not Joe’s group. I believe my moderation (filtering out the detritus you surely don’t need) is what keeps the group vibrant and alive.

But I sincerely hope and deeply encourage YOU(!) – yes, you reading this – to consider “what do I know about medical devices that other members likely don’t know,” and share it. As long as it’s not promotional and potentially valuable to the busy medical device executive, you’ll always have a platform here. 👍

Emanuel Weisgras
Bringing worlds and cultures together through language.
Thanks Joe!
Bill Paine, yes, exactly! The point is in fact to make sure the correct language and dialect are consistently used.
With regard to number 5, I’d add: A reputable company should also be able to provide CVs for the linguists they use (with identifying information redacted). We often include them as part of our certificates of accuracy (ie certificates of translation/validation).

Carmel McGrath
Regulatory Consultant & Trainer to Medtech Industry
Excellent points all. I’m training on the fundamentals of Global RA and will be sharing with my classes as important point to consider.

Kevin E. Flynn
Patent Attorney & Legal Counselor helping Emerging Companies located throughout the United States
Once you have a well-written IFU, it can be useful to share that with any patent attorney drafting a patent application. Care and attention is taken to make useful drawings for use in the IFU, it is low hanging fruit to allow the patent attorney to reuse these drawings. The IFU can provide a template to the patent attorney on the way that an end user would use the device. This can lay a foundation for a method claim for use in the US. Sometimes a broad method claim can be the hardest thing for a competitor to design around as the claim can be somewhat non-specific on some of the nuances of the device as it has the sequence of steps embedded in the claim. But frequently the sequence of steps will be intrinsic to the use and thus hard to avoid. It is my experience that the different groups within a medical device company can be in their own silos and the patent attorney only gets work product from the R&D silo not from some of the other silos. This is unfortunate but can be fixed.

Emanuel Weisgras
Bringing worlds and cultures together through language.
I would add a “6th Point” that reflects the theme underlying what Kevin E. Flynn said: Whether working internally with different teams or whether with outside service providers, communication is critical. Many mistakes, resulting “CAPAs,” etc. that we’ve encountered could have been avoided with better bilateral communication. Often, lack of communication stemmed from a client wanting to rush and “just get it done” without taking the time to understand the nature of and reason for questions and inquires from other team members and service providers. This can result in unnecessary added time and expense that could have been avoided by taking an extra day to discuss the project and consider modifying documents and/or instructions. Similarly, better communication inevitably leads to a better end result, often exceeding the scope of the client’s initial expectations.

Rochelle Stahl
In Vitro Diagnostics / Life Sciences / Medical Devices / Product Management / Strategy / Marketing
Great info. Review for many, but good to have all these points in one doc.

MANOHARAN GOVINDA PILLAI
Technical Director – Straits Orthopaedics (Mfg) Sdn Bhd
Hi Emanuel Weisgras, all points are highly valid information and I would like to agree with your last comment on point 5 as “request CVs for the linguists they use” which adds value to the document submission.

Beluh Mabasa Ginting
Section Head of Standardisation at Directorate of Supervision of Medical Devices and Household Health Ministry of Health
Good morning Medical Device group’s members. I would like to share information and questions like below.
IEC 60601-1:2005 article 7.9.1 * General
ME EQUIPMENT shall be accompanied by documents containing at least the instructions for use and a technical description. The ACCOMPANYING DOCUMENTS shall be regarded as a part of the ME EQUIPMENT.
ISO 15223-1:2012 article 3.4 labelling
information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device or any of its containers or wrappers
NOTE 1.This information relates to the identification, technical description and use of the medical device, but excludes shipping documents.
My question is, is the labelling, the test method, calibration method and wiring diagram of medical equipment shall be regarded as ACCOMPANYING DOCUMENTS .? who responsible to prepare the test method, calibration method and wiring diagram of medical equipment.? are the MANUFACTURER or RESPONSIBLE ORGANIZATION?

David Edwards
Head of Quality and Governance (Medical Physics) at University College London Hospitals NHS Foundation Trust
A medical device user should not rely on printed IFU. Depending (of course) on the device’s risk rating, the user should receive class-based training followed by competency assessment.
It’s useful if each device has a ‘Quick Reference’ laminated card attached (written, as you suggest, by a layperson), but this mustn’t replace properly assessed training.

Suniva Haule
BMEET
All are well said, but I would add another line to abide with technical documentations ie maintenance and PPM schedules for the device. Talking about a medical equipment(machine) be sure to provide the consumables for after sells service providers. For the under developed and developing countries they much prefer the re-use of the devices due to economic factors, which means they can not afford frequently replacing the equipment so after sells services are highly encouraged for these countries.

Bill P.
Supervisor, Global Technical Publications and Translations at Victor Technologies
Joe, great post
Adds 2. there is also Australian English to consider. 3. If your terms list (like a product name) requires special fonts, include them in the submission.
5. Excellent points here! Many agencies provide great services, but asking for that certificate of accuracy raises the quality bar.

Muhammad Sadiq
Founder and Senior Technical Officer at Active Needle Technology Ltd. / STEM Ambassador
Very useful, especially the point on IFU.

Valerie J Taylor
Research Professional/Pharmaceuticals/Medical Device
Regarding point #5, if using a third party supplier for translations, they should be able to provide a Certificate of Translation (CoT) and a Certificate of Validation (CoV). If unable to provide these two certificates, this may possibly mean the supplier does not employ translators who are ‘certified’ professionals.

Rick Rutherford
President/Principle at Rutherford MEDDEV Consulting
These are excellent points that should be adhered to without fail. Thanks for sharing them.

Damián Ramírez
Jefe de Esterilización en ICBA Instituto Cardiovascular de Buenos Aires
I live and work in Argentina. I agree with CEO Emanuel Weisgras about IFU. Sometimes I receive many medical devices imported from USA or Europe, and their IFU translated to Spanish are not so clear! Best regards.

Roger S. Reiss
PHOTONIC and MEDICAL INSTRUMENTS
Joe…Can I post some of this matter in my column,,,Roger S. Reiss…PHOTONIC INSTRUMENT DESIGN…You can post it my column which is open, no restrictions!!!Thanks, ROG