matrix Technical File Bakeng sa Sesebelisoa sa Bongaka

Tlhahisoleseding ya Sehlahiswa

Litlhaloso

• Lebitso la Sehlahisoa: Setsebi File bakeng sa Lisebelisoa tsa Bongaka
• Tumellano ea Taolo: Litlhoko tsa FDA le EU MDR
• Likaroloana tsa Bohlokoa: Tlhaloso ea Sesebelisoa, Leano la Taolo ea Likotsi, Litlaleho tsa Tlhahlobo ea Tleliniki, Litokomane tsa Tsamaiso ea Tsamaiso ea Boleng, Tlhahisoleseding ea Moqapi le Tlhahiso, Ho Ngola le Litaelo tsa Tšebeliso, Leano la ho Lekola 'Maraka

LBH

Ke likarolo life tsa bohlokoa tsa tekheniki file?

Likarolo tsa bohlokoa tsa tekheniki file kenyeletsa Tlhaloso ea Sesebelisoa le Litlhaloso, Leano la Taolo ea Likotsi, Litlaleho tsa Tlhahlobo ea Meriana, Litokomane tsa Tsamaiso ea Tsamaiso ea Boleng, Tlhahisoleseding ea Moqapi le Tlhahiso, Litlaleho le Litaelo tsa Tšebeliso, le Leano la ho Lekola 'Maraka.

Litlhokahalo tsa taolo bakeng sa lisebelisoa tsa bongaka US le EU ke life?

Kwa US, FDA e laola disebediswa tsa bongaka tse nang le ditlhoko tse kang Tsebiso ya Premarket (510(k)) kapa Premarket Approval (PMA), Quality System Regulation (QSR), le Litlhoko tsa ho Leibula. Kwa EU, EU MDR e hlakisa ditlhoko tse kang Tekanyetso ya Tekheniki, Tekolo ya Boitshwaro, Boitsebiso bo Ikgethileng ba Sesebediswa (UDI), le Tekolo le Tlhokomelo ka Morao Mmaraka.

Mokhoa oa ho hlophisa tekheniki ea hau file bakeng sa Sesebediswa sa hao sa Bongaka

A botekgeniki file ha se ntho e hlokahalang feela bakeng sa lisebelisoa tsa bongaka. Ha re sheba tataiso ea Blue bakeng sa ts'ebetsong ea melao ea lihlahisoa tsa EU, ho hlakile hore lihlahisoa tsohle tse oelang tlas'a molao oa Europe li hloka Tekheniki. File pele o dumellwa ho behoa mmarakeng. Joalo ka litokomane tsa tekheniki kapa tekheniki file e sebelisetsoa ho lekola hore na sesebelisoa se lumellana le litlhoko tsa taolo, ho bohlokoa ho ba le sebopeho se hlophisitsoeng hantle. file. Sena se tla nolofalletsa reviewho fumana tlhahisoleseding eo ba e batlang ka tsela e bonolo le e potlakileng, e leng se tla lebisa ho fokotseng ho se lumellane le nako e potlakileng ea ho rekisa.

Ho utloisisa Theknoloji File

Bakeng sa lisebelisoa tsa bongaka, tekheniki file ke pokello e felletseng ea litokomane tse fanang ka lintlha tse felletseng mabapi le sesebelisoa. E sebetsa e le rekoto ea moralo, nts'etsopele le ts'ebetso ea sesebelisoa, ho netefatsa hore se kopana le maemo a taolo mme se bolokehile ebile se sebetsa hantle bakeng sa tšebeliso. Morero oa mantlha oa tekheniki file ke ho bontša ho latela litlhokahalo tse amehang tsa taolo, ho fana ka bopaki ba hore sesebelisoa se entsoe le ho etsoa ho latela maemo le melaoana ea indasteri.
Likarolo tsa bohlokoa tsa tekheniki file ke:

1. Tlhaloso ea Sesebelisoa le Litlhaloso: Lintlha tse felletseng mabapi le sesebelisoa sa bongaka, ho kenyeletsoa ts'ebeliso ea sona, moralo, likarolo le litšobotsi tsa 'mele.
2. Moralo oa Taolo ea Likotsi: Tekolo e felletseng ea likotsi tse ka bang teng tse amanang le sesebelisoa, hammoho le maano a phokotso ho netefatsa polokeho.
3. Litlaleho tsa Tlhahlobo ea Meriana: Bopaki bo tsoang litekong tsa meriana kapa liphuputso tse bontšang polokeho le katleho ea sesebelisoa.
4. Litokomane tsa Tsamaiso ea Tsamaiso ea Boleng: Litlaleho tsa mekhoa le mekhoa e sebelisoang ho boloka boleng ho pholletsa le bophelo ba sesebelisoa.
5. Tlhahisoleseding ea Moralo le Tlhahiso: Litokomane tse qaqileng tsa ts'ebetso ea moralo, lisebelisoa tse sebelisoang, mekhoa ea tlhahiso, le mehato ea taolo ea boleng.
6. Ho Ngola le Litaelo tsa Tšebeliso: Boitsebiso bo fuoa basebelisi ba ho qetela, ho kenyeletsoa lileibole, ho paka le lisebelisoa tsa ho ruta.
7. Moralo oa ho lebela ka mor'a 'maraka: Leano la ho beha leihlo ts'ebetso ea sesebelisoa le polokeho ha se se se le 'marakeng.

Litlhoko tsa Taolo

Fetileview ea FDA le Litlhoko tsa EU MDR

Litlhoko tsa FDA
US Food and Drug Administration (FDA) e okametse taolo ea lisebelisoa tsa bongaka United States. Litlhoko tsa FDA bakeng sa tekheniki file, eo hangata e bitsoang Device Master Record (DMR) le Histori ea Moqapi File (DHF), e kenyelletsa:

• Tsebiso ea Premarket (510(k)) kapa Tumello ea Premarket (PMA)): Bopaki ba hore sesebelisoa se bolokehile ebile se sebetsa, ebang ke ka ho lekana ho hoholo ho sesebelisoa se rekisitsoeng ka molao kapa ka lintlha tse ngata tsa bongaka. Melao ea Tsamaiso ea Boleng (QSR):
• Litokomane tsa tsamaiso ea boleng ho latela 21 CFR Karolo ea 820 le ISO 13485.
• Litlhoko tsa ho Laela: Ho ngola ka mokhoa o hlakileng le o nepahetseng ho latela 21 CFR Karolo ea 801.

Litlhoko tsa EU MDR
European Union Medical Device Regulation (EU MDR) e hlalosa litlhoko tsa ho beha lisebelisoa tsa bongaka 'marakeng oa EU. Likarolo tsa bohlokoa li kenyelletsa:

• Litokomane tsa Tekheniki: Lintlha tse felletseng tse boletsoeng ho Annex II ea MDR, tse akaretsang moralo oa sesebelisoa, tlhahiso le tšebetso.
• Tekanyetso ea Tumellano: Mekhoa ea ho bonts'a boikamahanyo, ho kenyeletsoa ho kenya letsoho ha 'Mele oa Notified bakeng sa lisebelisoa tse kotsi haholo.
• Unique Device Identification (UDI): Sistimi ea ho ntlafatsa ho lateloa ha lisebelisoa tsa bongaka.
• Tlhokomelo le ho Falimeha ka mor'a Mmaraka: Tlhokomelo e tsoelang pele le tlaleho ea ts'ebetso ea lisebelisoa le liketsahalo tse mpe.

Phapang lipakeng tsa Litebello tsa Mekhatlo e Laolang

Leha FDA le EU MDR li ikemiselitse ho netefatsa polokeho le katleho ea lisebelisoa tsa bongaka, ho na le liphapang mekhoeng ea tsona:

• Bopaki ba Clinical: EU MDR hangata e hloka lintlha tse ngata tsa bongaka, haholo-holo bakeng sa lisebelisoa tse kotsi haholo.
• Sistimi ea Tsamaiso ea Boleng: Ka bobeli li hloka litsamaiso tse matla tsa taolo ea boleng, empa litlhoko tse ikhethileng le litokomane li ka fapana.
• Litlhoko tsa Kamor'a Mmaraka: EU MDR e hatisa ka matla ho lebela ka mor'a 'maraka le ho falimeha ka matla.

Bohlokoa ba ho Tsamaellana le Liphetoho tsa Taolo
Litlhoko tsa taolo bakeng sa lisebelisoa tsa bongaka li lula li fetoha. Ho lula u tseba ka liphetoho ho bohlokoa bakeng sa ho boloka melao le ho qoba tieho kapa likotlo tse bitsang chelete e ngata. Kamehla reviewho kenya lintlafatso tse tsoang mekhatlong e laolang, ho nka karolo liforamong tsa indasteri, le ho buisana le litsebi tsa taolo ho ka thusa bahlahisi ho boloka tekheniki ea bona. files hona joale ebile e lumellana.

Litokomane Tsa Bohlokoa

Tlhaloso ea Sesebelisoa le Litlhaloso
Tokomane ena e fana ka tlhaloso e feletsengview ea sesebelisoa sa bongaka, ho kenyelletsa:

• Tšebeliso e Reriloeng: Polelo e hlakileng ea morero oa bongaka o reriloeng oa sesebelisoa.
• Moralo le Kaho: Litlhaloso tse felletseng tsa moralo oa sesebelisoa, likarolo le thepa.
• Litlhaloso tsa Tekheniki: Litšobotsi tsa bohlokoa tsa ts'ebetso le litekanyetso tsa ts'ebetso.

Leano la Taolo ea Likotsi

Moralo oa taolo ea likotsi o hloaea likotsi tse ka bang teng tse amanang le sesebelisoa mme o hlalosa maano a ho li fokotsa. Sena se kenyelletsa:

• Tlhahlobo ea Kotsi: Ho tsebahatsa likotsi tse ka bang teng.
• Tekanyetso ea Kotsi: Tekanyetso ea monyetla le ho teba ha likotsi.
• Taolo ea Likotsi: Mehato ea ho fokotsa kapa ho felisa likotsi.
• Residual Risk Assessments: Tekolo ya dikotsi tse setseng ka mora hore ditaolo di kenngwe tshebetsong.
• Tlaleho ea Taolo ea Likotsi: Litokomane tsa ts'ebetso eohle ea taolo ea kotsi.

Litlaleho tsa Tlhahlobo ea Meriana

Litlaleho tsa tlhahlobo ea bongaka li fana ka bopaki ba polokeho le katleho ea sesebelisoa ka:

• Lithuto tsa Clinical: Lintlha tse tsoang litekong tsa bongaka le lithuto. Lingoliloeng Review: Tlhahlobo ea lintlha tsa kliniki tse hatisitsoeng ka lisebelisoa tse tšoanang.
• Lintlha tsa Post-Market: Lintlha tse bokelletsoeng ts'ebelisong ea sesebelisoa 'marakeng.

Litokomane tsa Tsamaiso ea Tsamaiso ea Boleng
Litokomane tsena li tiisa hore sesebelisoa se hlahisoa ka mokhoa o tsitsitseng mme se finyella litekanyetso tsa boleng. Likarolo tsa bohlokoa li kenyelletsa:

• Mekhoa e Tloaelehileng ea Ts'ebetso (SOPs): Mekhoa e felletseng ea likarolo tsohle tsa bophelo ba sesebelisoa. Litlaleho tsa Koetliso: Litokomane tsa koetliso ea basebetsi le bokhoni.
• Audit Reports: Liphetho tsa liphuputso tsa ka hare le tsa kantle tsa tsamaiso ea boleng.

Tlhahisoleseding ea Moralo le Tlhahiso
Karolo ena e kenyelletsa lintlha tse felletseng mabapi le moralo oa sesebelisoa le lits'ebetso tsa tlhahiso:

• Nalane ea Moqapi File (DHF): Litlaleho tsa ts'ebetso ea moralo, ho kenyeletsoa lipehelo tsa moralo, liphetho, reviews, le netefatso.
• Ts'ebetso ea Tlhahiso: Litlhaloso tse felletseng tsa mehato ea tlhahiso, lisebelisoa le tikoloho. Mehato ea Taolo ea Boleng: Mekhoa le mekhoa ea ho netefatsa boleng ba sehlahisoa.

Leibole le Litaelo tsa Tšebeliso
Leibole le litaelo tsa tšebeliso (IFU) li fana ka tlhaiso-leseling ea bohlokoa ho basebelisi, ho kenyelletsa:

• Li-Labels: Lileibole tse hlakileng le tse nepahetseng tse nang le lintlha tsa bohlokoa joalo ka lebitso la sesebelisoa, moetsi le litaelo tsa tšebeliso.
• Packaging: Tlhahisoleseding ea hore na sesebelisoa se phuthetsoe joang le litaelo tse itseng tsa ho sebetsana le tsona.
• IFU: Litaelo tse qaqileng tsa mokhoa oa ho sebelisa sesebelisoa ka mokhoa o sireletsehileng le ka katleho.

Moralo oa ho Lekola 'Maraka oa Post-Market
Moralo oa ho beha leihlo ka mor'a 'maraka o hlalosa kamoo ts'ebetso ea sesebelisoa le polokeho li tla beoa leihlo ka mor'a hore se be' marakeng. Sena se kenyelletsa:

• Pokello ea Lintlha: Mekhoa ea ho bokella lintlha mabapi le ts'ebetso ea sesebelisoa le liketsahalo tse mpe.
• Analysis: Mekhoa ea ho hlahloba lintlha tse bokelitsoeng. Ho tlaleha: Litlhoko tsa ho tlaleha liphetho ho mekhatlo ea taolo.

Mekhoa e Molemo ka ho Fetisisa ea ho Hlophisa Tekheniki ea Hao File

Malebela a ho Hlophisa Hao File bakeng sa ho Hlaka le ho Fumaneha

• Logic Organization: Litokomane tse amanang le lihlopha hammoho 'me u latele tatellano e utloahalang, joalo ka lifecycle s ea sesebelisoatages.
• Index le Lethathamo la Tse ka Hare: Fana ka index le lethathamo la litaba tse ka hare hore u tsamaee habonolo.
• Ho Femata ka ho Fetolana: Sebelisa mokhoa o tsitsitseng oa ho fometa le lithempleite bakeng sa litokomane tsohle ho netefatsa ho tšoana le ho baloa.

Tšebeliso ea Litsamaiso tsa Tsamaiso ea Litokomane tsa Elektronike
Litsamaiso tsa tsamaiso ea litokomane tsa elektronike (EDMS) li fana ka li-advan tse 'maloatages bakeng sa ho laola tekheniki files:

• Centralized Storage: Litokomane tsohle li bolokiloe sebakeng se le seng, se fumanehang.
• Ho batlisisa: Mesebetsi e ntlafalitsoeng ea ho batla bakeng sa ho fumana litokomane tse itseng kapele.
• Taolo ea Phihlello: Litumello le maemo a phihlello ho netefatsa polokeho ea litokomane.
• Audit Trails: Litlaleho tsa liphetoho tsa litokomane le nalane ea phihlello.

Taolo ea Phetolelo le Lintlafatso tsa Tokomane
Ho boloka taolo ea mofuta ho bohlokoa bakeng sa ho netefatsa hore litokomane tsa hajoale lia sebelisoa. Mekhoa e metle e kenyelletsa:

• Linomoro tsa mofuta: Fana ka linomoro tsa mofuta ho litokomane tsohle 'me u li nchafatse ka tokiso e ngoe le e ngoe.
• Fetola Li-Logs: Boloka lintlha tsa liphetoho tsohle tse entsoeng litokomaneng.
• Kamehla Reviews: Nako le nako review le ho nchafatsa litokomane ho bonts'a liphetoho tsa melaoana, theknoloji kapa mekhoa.

Likotsi Tse Tloaelehileng Tsa ho Qoba

Litokomane tse sa Feleng kapa Tse sieo
E 'ngoe ea litaba tse atileng haholo litokomaneng tsa tekheniki ke ho se be teng ha litokomane tse hlokahalang. Ho qoba sena:

• Manane a tlhahlobo: Sebelisa manane a hlahlobang ho netefatsa hore litokomane tsohle tse hlokahalang li kenyelelitsoe.
• Litlhahlobo tsa Kamehla: Etsa tlhahlobo ea khafetsa ea tekheniki ea hau file ho tseba le ho lokisa likheo.

Mekhoa e Fosahetseng ea Litokomane
Mekhoa e mebe ea litokomane e ka nyenyefatsa boleng le ts'epahalo ea tekheniki ea hau file. Qoba maraba ana ka:

• Koetliso: Netefatsa hore basebetsi bohle ba amehang litokomaneng ba koetlisoa ka mokhoa o nepahetseng ka mekhoa e metle.
• Lithempleite le Maemo: Sebelisa lithempleite tse tloaelehileng 'me u khomarele litekanyetso tsa litokomane.
• Boleng Reviews: Kenya tshebetsong boleng reviews ho tšoara le ho lokisa liphoso.

Ho iphapanyetsa Lintlafatso le Liphetoho tsa Taolo
Litlhoko tsa taolo li ka fetoha, 'me ho hloleha ho lula u nchafalitsoe ho ka fella ka ho se ikobele melao. Ho qoba sena:

• Lekola Mekhatlo ea Taolo: Kamehla beha leihlo lintlafatso tse tsoang mekhatlong e amehang ea taolo.
• Mekhatlo ea Indasteri: Ikopanye le mekhatlo ea indasteri ho lula u tseba ka liphetoho tsa taolo.
• Ikopanye le Litsebi: Sebetsa le baeletsi ba taolo kapa litsebi ho utloisisa le ho kenya tšebetsong litlhoko tse ncha.

Qetello

• Ho theha le ho boloka tekheniki e felletseng file bakeng sa lisebelisoa tsa bongaka ke tsa bohlokoa bakeng sa ho lumellana le taolo le ho netefatsa polokeho le katleho ea sesebelisoa. Ka ho utloisisa likarolo tsa bohlokoa, ho latela litlhoko tsa taolo, le ho latela mekhoa e metle ea litokomane, bahlahisi ba ka khona ho laola tekheniki ea bona ka nepo. files le ho qoba maraba a tloaelehileng. Ho lula u tseba ka liphetoho tsa taolo le ho tsoela pele ho ntlafatsa mekhoa ea litokomane ke habohlokoa bakeng sa khoebo e atlehileng le ho beha leihlo le tsoelang pele la lisebelisoa tsa bongaka.
• Ho kenya ts'ebetsong mekhoa e metle ho netefatsa litokomane tse hlophisitsoeng hantle, ho ka potlakisa haholo ts'ebetso ea tumello ea lisebelisoa. MatrixALM e etselitsoe ho u thusa ho qeta nako e eketsehileng ho nts'etsopele ea sesebelisoa sa hau le ho thusa ho hlahisa litokomane tse hlokahalang. Ha re sheba lipale tsa bareki ba rona, re bona lintlafatso tse kholo nakong ea ho hlahisa litokomane le nako eo e e nkang ho etsa lihlahlobo.
• Haeba u ka rata ho tseba hore na Matrix e ka u thusa joang ho tlisa sesebelisoa sa hau 'marakeng ka potlako, u seke oa tsilatsila ho beha demo!

Litokomane / Lisebelisoa

matrix Technical File Bakeng sa Sesebelisoa sa Bongaka [pdf] Bukana ea Mosebelisi Setsebi File Bakeng sa Sesebelisoa sa Bongaka, Tekheniki, File Bakeng sa Sesebelisoa sa Bongaka, Sesebelisoa sa Bongaka, Sesebelisoa

Litšupiso

• Bukana ea Mosebelisi