Regulatory Open Forum

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.

I have a client who is working on translations. (In my MDR classes I tell people to buy stock in a good translation company.)

We are looking at machine translation as an option for small jobs such as a sentence or two in an IFU. Today, the problem came up with the free-form fields in the Eudamed UDI database. MDCG 2018-7 says that in general any free-text field should be in English as well as in the languages of those countries where the device is available. A data field will be available for each relevant language.

Translation companies may use machine translation following ISO 17100:2015 Translation services – Requirements for translation services.

Another area with translation is the SSCP. Simply, the process in MDCG 2019-9 has the manufacturer submit the draft SSCP in English. The NB reviews it and, when acceptable, posts it to Eudamed. The manufacturer has it translated and "should ensure, through their quality management system, that the translations are correct". This opens the possibility of the manufacturer being the translator through machine translation.

Two (at least) on-line services have relevance – Google translate and Microsoft. There is a Microsoft web page that discusses breakthroughs in machine translation using AI. Also, the article says that Microsoft uses its own translation software, available in MS Office, for all of its manuals and technical documentation.

I want to explore the possibility of a small manufacturer using machine translation as part of the QMS. The QMS would have the associated processes, work instructions, methods, etc. An example process would write a short statement in English, such as for UDI, translate it into the target language using MS Word, then translate the output back to English and see if it is reasonable.

Of course, there are problems. Many years ago, as I recall, a machine translation of "The flesh is willing but spirit is weak" came back as "The meat is good, but the wine in awful".

One of my favorites for ambiguity is "Time flies like an arrow" which obviously means there is a kind of fly, perhaps like a house fly, that prefer to eat arrows – an ever present danger at archery ranges.

More seriously, I would like to see if anybody else is working in this area. Also, I would appreciate any thoughts about feasibility.