matrix Technical File Okwedivayisi Yezokwelapha

Ulwazi Lomkhiqizo

Imininingwane

• Igama Lomkhiqizo: Technical File Yamadivayisi Ezokwelapha
• Ukuthobela Umthetho: Izidingo ze-FDA kanye ne-EU MDR
• Izingxenye Ezibalulekile: Incazelo Yedivayisi, Uhlelo Lokulawulwa Kwengozi, Imibiko Yokuhlolwa Komtholampilo, Ukubhalwa Kwesistimu Yokuphathwa Kwekhwalithi, Ulwazi Lokuklama Nokukhiqiza, Ukulebula kanye Nemiyalelo Yokusetshenziswa, Uhlelo Lokubhekwa Kwemakethe Emuva Kwemakethe

FAQ

Yiziphi izingxenye eziyinhloko ze-technical file?

Izingxenye ezibalulekile ze-technical file zihlanganisa Incazelo Nemininingwane Yedivayisi, Uhlelo Lokulawulwa Kwengozi, Imibiko Yokuhlolwa Komtholampilo, Ukubhalwa Kwesistimu Yokuphathwa Kwekhwalithi, Ulwazi Lokuklama Nokukhiqiza, Ukulebula Nemiyalelo Yokusetshenziswa, kanye Nohlelo Lokubhekwa Kwemakethe Emuva Kwemakethe.

Yiziphi izimfuneko zokulawula zemishini yezokwelapha e-US nase-EU?

E-US, i-FDA ilawula amadivayisi ezokwelapha anezidingo ezifana nesaziso Semakethe Ngaphambi Kwemakethe (510(k)) noma Ukuvunyelwa Kwemakethe Ngaphambili (PMA), Ukulawulwa Kwesistimu Yekhwalithi (QSR), kanye Nezimfuneko Zokulebula. E-EU, i-EU MDR iveza izidingo ezifana ne-Technical Documentation, Conformity Assessment, Unique Device Identification (UDI), kanye Nokuqapha Nokuqapha Kwangemva Kwemakethe.

Ungahlela kanjani ubuchwepheshe bakho file Yedivayisi yakho Yezokwelapha

A lobuchwepheshe file akuyona into edingekayo kuphela ezinsizeni zezokwelapha. Uma sibheka umhlahlandlela Oluhlaza okwesibhakabhaka wokusetshenziswa kwemithetho yemikhiqizo ye-EU, kuyacaca ukuthi yonke imikhiqizo ewela ngaphansi komthetho waseYurophu idinga Ubuchwepheshe. File ngaphambi kokuvunyelwa ukufakwa emakethe. Njengemibhalo yezobuchwepheshe noma yezobuchwepheshe file isetshenziselwa ukuhlola ukuthi idivayisi iyahambisana yini nezidingo zokulawula, kubalulekile ukuthi ibe nesakhiwo esihle file. Lokhu kuzovumela i-reviewukuze bathole ulwazi abalufunayo ngendlela elula nesheshayo, okuzoholela ekunciphiseni ukungahambisani nesikhathi kanye nesikhathi esisheshayo sokumaketha.

Ukuqonda Ubuchwepheshe File

Okwemishini yezokwelapha, i-technical file iqoqo eliphelele lamadokhumenti anikeza imininingwane enemininingwane mayelana nocingo. Isebenza njengerekhodi lokuklama, ukuthuthukiswa, nokusebenza kwedivayisi, iqinisekisa ukuthi ihlangabezana nezindinganiso zokulawula futhi iphephile futhi iyasebenza ukuze isetshenziswe. Inhloso eyinhloko ye-technical file ukukhombisa ukuthobela izimfuneko zomthetho ezifanele, ukunikeza ubufakazi bokuthi idivayisi iklanywe futhi yakhiqizwa ngokuvumelana namazinga nemithetho yemboni.
Izingxenye ezibalulekile ze-technical file yilezi:

1. Incazelo Yedivayisi Nemininingwane: Ulwazi oluningiliziwe mayelana nedivayisi yezokwelapha, okuhlanganisa ukusetshenziswa kwayo okuhlosiwe, ukwakheka, izingxenye, nezici zomzimba.
2. Uhlelo Lokulawula Ubungozi: Ukuhlolwa okuphelele kwezingozi ezingaba khona ezihlobene nocingo, kanye namasu okunciphisa ukuze kuqinisekiswe ukuphepha.
3. Imibiko Yokuhlolwa Komtholampilo: Ubufakazi obuvela ezivivinyweni zomtholampilo noma izifundo ezibonisa ukuphepha nokusebenza ngempumelelo kwedivayisi.
4. Ukubhalwa Kwesistimu Yokuphatha Ikhwalithi: Amarekhodi ezinqubo nezinqubo ezisetshenziselwa ukugcina ikhwalithi kuwo wonke umjikelezo wempilo wedivayisi.
5. Ulwazi Lokuklama Nokukhiqiza: Imibhalo enemininingwane yenqubo yokuklama, izinto ezisetshenziswayo, izindlela zokukhiqiza, nezinyathelo zokulawula ikhwalithi.
6. Ukulebula Nemiyalelo Yokusetshenziswa: Ulwazi olunikezwa abasebenzisi bokugcina, okuhlanganisa amalebula, ukupakisha, nezinto zokufundisa.
7. I-Post-Market Surveillance Plan: Isu lokuqapha ukusebenza nokuphepha kwedivayisi uma isisemakethe.

Izidingo Zokulawula

Kuphelileview ye-FDA kanye ne-EU MDR Izidingo

Izidingo ze-FDA
I-US Food and Drug Administration (FDA) yengamela ukulawulwa kwemishini yezokwelapha e-United States. Izidingo ze-FDA zezobuchwepheshe file, evame ukubizwa ngokuthi i-Device Master Record (DMR) kanye Nomlando Wokuklama File (DHF), kufaka phakathi:

• Isaziso Semakethe Ngaphambi Kwemakethe (510(k)) noma Ukuvunyelwa Kwemakethe Ngaphambili (PMA)): Ubufakazi bokuthi idivayisi iphephile futhi iyasebenza, ngokulingana okukhulu kudivayisi emakethe ngokusemthethweni noma ngedatha ebanzi yomtholampilo. I-Quality System Regulation (QSR):
• Ukubhalwa kwesistimu yokuphatha ikhwalithi ngokuhambisana ne-21 CFR Ingxenye 820 kanye ne-ISO 13485.
• Izidingo Zokulebula: Ukulebula okucacile nokunembile ngokuhambisana ne-21 CFR Ingxenye 801.

Izidingo ze-EU MDR
I-European Union Medical Device Regulation (EU MDR) ichaza izidingo zokubekwa kwemishini yezokwelapha emakethe ye-EU. Izingxenye ezibalulekile zifaka:

• Amadokhumenti Obuchwepheshe: Ulwazi oluningiliziwe olucaciswe kuSijobelelo II se-MDR, olufaka ukwakheka kwedivayisi, ukukhiqizwa, nokusebenza.
• Ukuhlola Ukuvumelana: Izinqubo zokubonisa ukuthobelana, okuhlanganisa ukubandakanyeka Komzimba Owazisiwe kumadivayisi anobungozi obukhulu.
• I-Unique Device Identification (UDI): Uhlelo lokuthuthukisa ukulandeleka kwamadivayisi ezokwelapha.
• Ukubhekwa Nokuqapha Kwangemuva Kwemakethe: Ukuqapha okuqhubekayo nokubikwa kokusebenza kwedivayisi nemicimbi emibi.

Umehluko Phakathi Kokulindelwe Izinhlaka Ezilawulayo

Nakuba kokubili i-FDA ne-EU MDR ihlose ukuqinisekisa ukuphepha nokusebenza ngempumelelo kwemishini yezokwelapha, kunomehluko ezindleleni zazo:

• Ubufakazi Bomtholampilo: I-EU MDR ivamise ukudinga idatha yomtholampilo ebanzi, ikakhulukazi kumadivayisi anobungozi obukhulu.
• Amasistimu Okuphatha Ikhwalithi: Womabili adinga amasistimu okuphatha ikhwalithi aqinile, kodwa izidingo ezithile kanye nemibhalo kungase kuhluke.
• Izidingo Zangemva Kwemakethe: I-EU MDR igcizelela kakhulu ukubhekwa kwangemva kwemakethe kanye nokuqapha okuqinile.

Ukubaluleka Kokuhambisana Nezinguquko Zokulawula
Izidingo zokulawula zemishini yezokwelapha zithuthuka ngokuqhubekayo. Ukuhlala unolwazi mayelana nezinguquko kubalulekile ekugcineni ukuthobela nokugwema ukubambezeleka okubizayo noma izinhlawulo. Njalo kabushaviewukwamukela izibuyekezo ezivela emigwaqweni elawulayo, ukubamba iqhaza ezinkundleni zokuxhumana, kanye nokuxhumana nochwepheshe bezokulawula kungasiza abakhiqizi bagcine ubuchwepheshe babo. files zamanje futhi ziyahambisana.

Amadokhumenti Abalulekile

Incazelo Yedivayisi Nemininingwane
Lo mbhalo unikeza incazelo epheleleview kwensiza yezokwelapha, okuhlanganisa:

• Ukusetshenziswa Okuhlosiwe: Isitatimende esicacile senhloso yezokwelapha ehlosiwe yocingo.
• Idizayini Nokwakha: Izincazelo ezinemininingwane zokwakheka kwedivayisi, izingxenye, nezinto zokwakha.
• Ukucaciswa kobuchwepheshe: Izici zokusebenza ezibalulekile nemingcele yokusebenza.

Uhlelo Lokulawulwa Kwengozi

Uhlelo lokulawula ubungozi luhlonza ubungozi obungaba khona obuhlobene nedivayisi futhi luveza amasu okubunciphisa. Lokhu kuhlanganisa:

• Ukuhlaziywa Kwengozi: Ukuhlonzwa kwezingozi ezingaba khona.
• Ukuhlola Ubungozi: Ukuhlolwa kwamathuba kanye nobukhulu bezingcuphe.
• Ukulawulwa Kwengozi: Izinyathelo zokunciphisa noma zokuqeda ubungozi.
• Ukuhlola Ubungozi Obusele: Ukuhlolwa kwezingcuphe ezisele ngemva kokuqaliswa kokulawula.
• Umbiko Wokulawulwa Kwengozi: Ukubhalwa kwayo yonke inqubo yokulawulwa kobungozi.

Imibiko Yokuhlolwa Komtholampilo

Imibiko yokuhlolwa komtholampilo inikeza ubufakazi bokuphepha nokusebenza kwedivayisi ngokusebenzisa:

• Izifundo Zemitholampilo: Idatha evela ezivivinyweni zomtholampilo nezifundo. Izincwadi Review: Ukuhlaziywa kwedatha yomtholampilo eshicilelwe kumadivayisi afanayo.
• Idatha ye-Post-Market: Ulwazi oluqoqwe kusukela ekusetshenzisweni kwedivayisi emakethe.

Ukubhalwa Kwesistimu Yokuphatha Ikhwalithi
Lawa madokhumenti aqinisekisa ukuthi idivayisi ikhiqizwa ngendlela efanayo futhi ihlangabezana nezindinganiso zekhwalithi. Izingxenye ezibalulekile zifaka:

• Izinqubo Ezijwayelekile Zokusebenza (ama-SOP): Izinqubo ezinemininingwane yazo zonke izici zomjikelezo wempilo wedivayisi. Amarekhodi Okuqeqesha: Amadokhumenti okuqeqeshwa kwabasebenzi kanye nekhono.
• Imibiko yoCwaningo: Imiphumela yocwaningomabhuku lwangaphakathi nangaphandle kohlelo lokuphatha ikhwalithi.

Ulwazi Lokuklama Nokukhiqiza
Lesi sigaba sihlanganisa imininingwane egcwele mayelana nedizayini yedivayisi nezinqubo zokukhiqiza:

• Umlando Wokuklama File (DHF): Amarekhodi enqubo yokuklama, okuhlanganisa okokufaka kwedizayini, okuphumayo, kabushaviews, kanye nokuqinisekisa.
• Inqubo Yokukhiqiza: Izincazelo ezinemininingwane zezinyathelo zokukhiqiza, okokusebenza, nendawo. Izinyathelo Zokulawula Ikhwalithi: Izinqubo nemibandela yokuqinisekisa ikhwalithi yomkhiqizo.

Ukulebula kanye Nemiyalelo Yokusetshenziswa
Ukulebula nemiyalelo yokusetshenziswa (IFU) inikeza ulwazi olubalulekile kubasebenzisi, okuhlanganisa:

• Amalebula: Amalebula acacile nanembile anolwazi olubalulekile njengegama ledivayisi, umkhiqizi, nemiyalelo yokusetshenziswa.
• Ukupakisha: Ulwazi lokuthi idivayisi ipakishwe kanjani nanoma yimiphi imiyalelo ethile yokusingatha.
• IFU: Imiyalelo enemininingwane yokuthi ungalusebenzisa kanjani ucingo ngokuphepha nangempumelelo.

I-Post-Market Surveillance Plan
Uhlelo lokugada lwangemva kwemakethe luchaza ukuthi ukusebenza nokuphepha kwedivayisi kuzoqashelwa kanjani ngemva kokuba semakethe. Lokhu kuhlanganisa:

• Ukuqoqwa Kwedatha: Izindlela zokuqoqa idatha ekusebenzeni kwedivayisi nezehlakalo ezingezinhle.
• Ukuhlaziya: Izinqubo zokuhlaziya idatha eqoqiwe. Ukubika: Izidingo zokubika okutholakele emigwaqweni elawulayo.

Imikhuba Engcono Kakhulu Yokuhlela Ubuchwepheshe Bakho File

Amathiphu Okwenza Isakhiwo Sakho File ukuze Kucace kanye Nokufinyelela

• Inhlangano Enengqondo: Hlanganisa amadokhumenti ahlobene ndawonye futhi alandele ukuhleleka okunengqondo, okufana nomjikelezo wempilo wedivayisitages.
• Inkomba kanye Nohlu Lokuphakathi: Nikeza inkomba kanye nohlu lokuqukethwe ukuze uthole ukuzulazula kalula.
• Ukufometha Okufanayo: Sebenzisa ukufometha okungaguquki nezifanekiso zawo wonke amadokhumenti ukuze uqinisekise ukufana nokufundeka.

Ukusetshenziswa Kwezinhlelo Zokulawulwa Kwemibhalo Ye-elekthronikhi
Izinhlelo zokuphatha amadokhumenti e-elekthronikhi (EDMS) zinikeza ama-advan ambalwatages yokuphatha ubuchwepheshe files:

• Isitoreji Esimaphakathi: Yonke imibhalo igcinwa endaweni eyodwa, efinyelelekayo.
• Ukusesheka: Imisebenzi yokusesha ethuthukisiwe yokuthola amadokhumenti athile ngokushesha.
• Ukulawula Ukufinyelela: Izimvume namazinga okufinyelela ukuze kuqinisekiswe ukuphepha kwedokhumenti.
• Izindlela Zokucwaninga: Amarekhodi ezinguquko zedokhumenti nomlando wokufinyelela.

Ukulawulwa Kwenguqulo kanye Nokubuyekezwa Kwedokhumenti
Ukugcina ukulawulwa kwenguqulo kubalulekile ekuqinisekiseni ukuthi imibhalo yamanje kakhulu iyasetshenziswa. Imikhuba emihle ihlanganisa:

• Izinombolo Zenguqulo: Nikeza izinombolo zenguqulo kuwo wonke amadokhumenti futhi uwabuyekeze ngesibuyekezo ngasinye.
• Shintsha Amalogi: Gcina amalogi azo zonke izinguquko ezenziwe kumadokhumenti.
• I-Regular Reviews: Ngezikhathi kabushaview futhi ubuyekeze amadokhumenti ukuze abonise izinguquko kumithethonqubo, ubuchwepheshe, noma izinqubo.

Izingibe Ezivamile Okufanele Zigwenywe

Amadokhumenti Angaphelele noma Angekho
Enye yezinkinga ezivame kakhulu emibhalweni yezobuchwepheshe ukushiywa kwemibhalo edingekayo. Ukuze ugweme lokhu:

• Izinhla zokuhlola: Sebenzisa izinhla zokuhlola ukuqinisekisa ukuthi wonke amadokhumenti adingekayo afakiwe.
• Ukucwaningwa Kwamabhuku Okuvamile: Yenza ukuhlolwa okujwayelekile kobuchwepheshe bakho file ukukhomba nokulungisa izikhala.

Imikhuba Emibi Yemibhalo
Izinqubo zokubhala ezingezinhle zingabukela phansi ikhwalithi nokuthembeka kobuchwepheshe bakho file. Gwema lezi zingibe ngokuthi:

• Ukuqeqeshwa: Qinisekisa ukuthi bonke abasebenzi abathintekayo ekubhalweni baqeqeshwe ngendlela efanele emisebenzini engcono kakhulu.
• Izifanekiso Namazinga: Sebenzisa izifanekiso ezimisiwe futhi unamathele kumazinga okubhalwa kwemibhalo.
• Ikhwalithi Reviews: Sebenzisa kabusha ikhwalithiviews ukubamba nokulungisa amaphutha.

Ukuziba Izibuyekezo Nezinguquko Zokulawula
Izimfuneko zokulawula zingashintsha, futhi ukwehluleka ukuhlala unolwazi kungase kubangele ukungathobeli. Ukuze ugweme lokhu:

• Gada Izindikimba Zokulawula: Qaphela njalo izibuyekezo ezivela ezigungwini ezilawulayo ezifanele.
• Izinhlangano Zomkhakha: Joyina izinhlangano zezimboni ukuze uhlale unolwazi mayelana nezinguquko zokulawula.
• Xhumana Nochwepheshe: Sebenzisana nabeluleki abalawulayo noma ochwepheshe ukuze uqonde futhi usebenzise izidingo ezintsha.

Isiphetho

• Ukudala nokugcina ubuchwepheshe obuphelele file kumishini yezokwelapha kubalulekile ukuze kuthotshelwe umthetho kanye nokuqinisekisa ukuphepha nokusebenza ngempumelelo kocingo. Ngokuqonda izingxenye ezibalulekile, ukunamathela ezidingweni zokulawula, nokulandela izinqubo ezingcono kakhulu zokwenziwa kwemibhalo, abakhiqizi bangakwazi ukuphatha ngempumelelo ubuchwepheshe babo. files futhi ugweme izingibe ezivamile. Ukuhlala unolwazi mayelana nezinguquko zokulawula kanye nokwenza ngcono ngokuqhubekayo izinqubo zokubhalwa kwemibhalo kubalulekile ukuze kwenziwe ukuhweba ngempumelelo kanye nokuqapha okuqhubekayo kwemishini yezokwelapha.
• Ukusebenzisa izinqubo ezingcono kakhulu zokuqinisekisa imibhalo eyakhiwe kahle, kungasheshisa kakhulu inqubo yokugunyaza yamadivayisi. I-MatrixALM yakhelwe ukukusiza ukuthi uchithe isikhathi esiningi ekuthuthukisweni kwedivayisi yakho futhi usize ukukhiqizwa kwemibhalo edingekayo. Uma sibheka izindaba zamakhasimende ethu, sibona ukuthuthuka okuphawulekayo ngesikhathi sokwenza amadokhumenti kanye nesikhathi esisithathayo ukuze kuphumelele ukuhlolwa.
• Uma ungathanda ukwazi ukuthi i-Matrix ingakusiza kanjani ukuletha idivayisi yakho emakethe ngendlela esheshayo, ungangabazi ukubhuka idemo!

Amadokhumenti / Izinsiza

matrix Technical File Okwedivayisi Yezokwelapha [pdf] Umhlahlandlela Womsebenzisi Ezobuchwepheshe File Okwedivayisi Yezokwelapha, Ezobuchwepheshe, File Okwedivayisi Yezokwelapha, Idivayisi Yezokwelapha, Idivayisi

Izithenjwa

• Imaniwali yosebenzisayo