Fa nhwehwɛmu du yi toto wɔn a wɔyɛ nnompe a wɔde hyɛ nipadua mu ho wɔ mmara kwan so, sɛnea wotumi hwehwɛ nneɛma mu, sɛnea wɔhwɛ sɛnea nneɛma te, sɛnea wɔyɛ krado, aguadi ho nsɛm ne mmoa a wɔde ma bere tenten ho —ɛnyɛ bo a wɔka nkutoo ho.
Mmuae ntɛm
Ɛsɛ sɛ nnompe a wɔde hyɛ nipadua mu yɛfo a wotumi de ho to no so tumi de adanse ma —ɛnyɛ bɔhyɛ ahorow nko —a ɛfa ne mmara kwan so nipasu, nea ɛfa sɛnea wɔhwɛ so yiye, gua so tumi krataa a ɛfa ade pɔtee bi ho, nneɛma a wotumi hwehwɛ nneɛma mu, sɛnea wɔyɛ no ne sɛnea wɔyɛ no ho adansedi, tumi a wɔde yɛ, OEM nsɛm, nneɛma a wɔde ma ho nhyehyɛe, anwiinwii ho dwumadie ne nsɛm a ɛfa wo gua ho.
Fi ase de nkrataa fi ase, hwɛ sɛ ɛyɛ nokware wɔ w’ankasa mu, hwɛ sɛnea adwumayɛbea no de ne nhyehyɛe ahorow di dwuma, na wie nhwɛsode a wɔahyɛ so a wɔahyɛ ansa na woahyɛ bɔ bere tenten.
Sɛ́ wobɛpaw obi a ɔyɛ nnompe a wɔde hyɛ nipadua mu no yɛ asiane ho gyinaesi. Sɛ adansedi krataa no dodow nhyia, nnwinnade no nwie pɛyɛ, nkrataa a wɔde kyerɛw wɔn din no kyɛ, anaasɛ wontumi mfa wɔn ho nto so sɛ wɔbɛsan de ahyɛ mu ma a, sika a wɔde ma a ɛba fam betumi ayɛ nea ne bo yɛ den. Bere koro no ara mu no, wɛbsaet a wɔayɛ no fɛfɛɛfɛ anaasɛ nneɛma a wɔde yɛ nneɛma ho nhoma tenten nkyerɛ sɛ nea ɔyɛ no betumi adi gua a wode w’ani asi so no ahwehwɛde ahorow ho dwuma.
Wɔayɛ akwankyerɛ yi ama amanaman ntam nnompe mu nnuru a wɔkyekyɛ, wɔn a wɔde nneɛma ba amannɔne, ayaresabea adetɔ akuw ne ankorankoro a wɔtɔ nneɛma. Ɛtwe adwene si nsɛmmisa ne adanse a ehia ansa na wɔn a wɔde nneɛma ma no apene so. Ɛnsi mmara mu nhwehwɛmu, su pa ho nhwehwɛmu, mmara mu nhwehwɛmu anaa ayaresabea nhwehwɛmu ananmu.
Nwoma a ɛsɛ sɛ wobisa ansa na wode nsɛm a wɔafa aka atoto ho
Bisa adwumakuw biara a wɔapaw no tiawa no adanse koro no ara. Adesrɛ a wɔahyɛ da ayɛ no ma ntotoho yɛ mmerɛw na ɛtew asiane a ɛwɔ hɔ sɛ wɔbɛpaw adwumakuw bi esiane sɛ ɛde aguadi ho nneɛma a ɛyɛ anigye—nanso enni mũ—mae nti.
| Hwɛ beae no | Adanse a ɛsɛ sɛ wobisa | Nea ɛsɛ sɛ wodi ho adanse | Kɔkɔbɔ sɛnkyerɛnne a wɔtaa de di dwuma |
|---|---|---|---|
| Adwumakuw no ho nkyerɛkyerɛmu | Adwumayɛ tumi krataa, adwumayɛbea address ne mmara kwan so adwumayɛfo ho nsɛm | Ɔyɛ apam no, nea ɔyɛ ne nea ɔwɔ adansedi krataa no wɔ abusuabɔ pefee | Wɔde aguadi adwumakuw bi kyerɛ sɛ mmara kwan so adeyɛfo a wɔankyerɛkyerɛ mu |
| Nhyehyɛe a ɛyɛ papa | Mprempren ISO 13485 adansedi krataa ne ne kɛse | Issuer, validity, address, dwumadi ne nneɛma ahorow a wɔakata so | Adansedie krataa no atwam anaasɛ ne kɛseɛ ntumi nka nneɛma a wɔabisa no ho |
| Guadidan mu kwan a wɔfa so nya | Product-specific registrations, clearances, adansedie nkrataa anaa mpaemuka | Model din, gua a wɔpɛ sɛ wɔyɛ, adansedi krataa nɔma ne mprempren tebea | Wɔka adwumakuw a wɔkyerɛw wɔn din ho asɛm sɛ wɔpene nneɛma biara so |
| Traceability a wotumi hwehwɛ mu | Nhwɛsoɔ nneɛma adansedie krataa, lot kyerɛwtohɔ, akwantufoɔ ne nhwehwɛmu kyerɛwtohɔ | Kyerɛwtohɔ ahorow ka raw material, production lot ne finished product ho | Generic material specification nkutoo na ɛwɔ hɔ |
| Validation a wɔde ma | Nsusuwii a ɛfata, mfiridwuma, ɔkwan a wɔfa so yɛ, ahotew ne nneɛma a wɔde kyekyere nneɛma ho adanse | Adanse no fa nhwɛso ne nhyehyɛe a wɔabisa no ho | Sɔhwɛ mu nsɛm tiawa yi nhwɛsode nɔma, akwan anaa gyinapɛn ahorow a wɔde gye tom no fi mu |
| Supply adwumayɛ | Capacity statement, standard lead times ne nnansa yi delivery data | Quoted lead time kyerɛ tumi ankasa ne inventory a ɛwɔ hɔ | Wɔka ahyɛde biara ho asɛm sɛ ɛyɛ nea etumi yɛ ntɛm a enni data a ɛfoa so |
| Nneɛma a wɔtɔn akyi a wɔhwɛ so | Anwiinwii, CAPA, anidasoɔ ne nkaeɛ nhyehyɛeɛ | Wɔakyerɛkyerɛ asɛyɛde ahorow ne mmere a wɔde kɔ soro no mu | Adeyɛ biara nni hɔ a wɔakyerɛw ho asɛm wɔ bere a wɔde amena akyi |
1Si adwumakuw no mmara kwan so nipasu ne adwuma a wɔyɛ wɔ nneɛma a wɔyɛ mu no so dua
Di kan kyerɛ onii a ɔbɛyɛ nneɛma a wɔde bɛhyɛ nipadua no mu no, hena na ɔwɔ adwini ne ne din a wɔakyerɛw, onii a obepue wɔ krataa no so, ne onii a ɔde ne nsa bɛhyɛ apam no ase. 'Ɔdemafo,' 'factory,' 'brand owner' ne 'mmara kwan so yɛfo' nyɛ adwuma koro no ara.
Fa adwumakuw no din ne address a wɔakyerɛ wɔ adwumayɛ tumi krataa, quality-system certificate, product documentation, quotation, label artwork ne bank account toto ho. Sɛ nnwumakuw ahorow na wɔde wɔn ho hyɛ mu a, bisa sɛ wɔkyerɛw wɔn nkyerɛkyerɛmu wɔ wɔn dwumadi ne apam mu abusuabɔ ho.
- Hwɛ address a wɔde yɛ nneɛma a ɛwɔ hɔ ankasa no mu, ɛnyɛ address a ɛwɔ adwumayɛbea a wɔtɔn nneɛma no nkutoo.
- Bisa sɛ nneɛma bɛn na wɔyɛ wɔ fie hɔ ne nea wɔde ma afoforo.
- Si nea ɔhwɛ nsakrae a wɔyɛ wɔ nhyehyɛe mu, mfiridwuma ho fael ne anwiinwii nhwehwɛmu so no so dua.
- Wɔ private-label projects ho no, kyerɛ ɔfã a wɔbɛyɛ registrations wɔ gua biara so.
2Hwɛ sɛnea quality-system scope ne product-specific gua so tumi krataa
ISO 13485 yɛ aduruyɛ-mfiri pa-hwɛ gyinapɛn, nanso ɛsɛ sɛ wɔhwɛ adansedi krataa bi mu wɔ nsɛm a ɛfa ho mu. Hwɛ mmara kwan so adwumakuw, beae no address, dwumadi ahorow a wɔakata so, nneɛma ahorow, nna a wɔde ma ne nea ɛtwam, ne adansedi kuw no tebea. Adansedi krataa a ɛfata yɛ mfiase a ɛho hia; ɛnyɛ nea wɔde besi adanse a ɛfa nneɛma pɔtee bi ho ananmu.
Wɔ United States deɛ, nnye 'FDA a wɔakyerɛw so' anaa 'FDA adansedie' ntom sɛ adanseɛ a ɛkyerɛ sɛ wɔaprapra afiri bi mu anaa wɔapene so. FDA ka sɛ establishment registration ne device listing nkyerɛ sɛ wɔapene so, wɔagye atom anaasɛ wɔama ho kwan. Bisa nneɛma no nkyekyɛmu a ɛfata ne nsɛm a wɔde kɔma ansa na wɔatɔn, baabi a ɛho hia, na hwɛ sɛ ɛyɛ nokware wɔ FDA database a ɛfa ho no mu.
Wɔ Europa Aman Nkabom Kuo no fam no, hwɛ dwumadie a ɔyɛfoɔ no di wɔ Mmara (EU) 2017/745, ɔkwan a ɛfa so a wɔfa so hwehwɛ nsɛm a ɛne ne ho hyia, mpaemuka a ɛkyerɛ sɛ ɛne ne ho hyia ne adansedie krataa no kɛseɛ. Baabi a ɛfata no, fa Europafoɔ aban ahodeɛ te sɛ EUDAMED so di amanneɛbɔ-kuo ne adansedie ho nsɛm ho adanseɛ.
Mfa ahyɛnsode ahorow so nnye obi a ɔde nneɛma ma no ntom
ISO, CE ne FDA ahyɛnsode ahorow a ɛwɔ nhomawa bi mu no nyɛ adanse a ɛdɔɔso. Kyerɛw adansedi krataa anaa nɔma a wɔde mena no pɛpɛɛpɛ, mmara kwan so adwumakuw a wɔakata so, nneɛma abusua, nhwɛso ne gua a wɔde wɔn ani asi so, afei hwɛ ade biara mu wɔ ahofadi mu.
Nhwɛsoɔ a ɛfa adansedie nkrataa a XC Medico de ama ho
Mfonini ahorow a ɛwɔ aseɛ ha yi yɛ nkrataa nhwɛsoɔ a wɔde bɛsan ahwɛ mu mfitiaseɛ. Ansa na nea ɔde ma no bɛpene so no, bisa mprempren mfonini ahorow a ɛyɛ pɛpɛɛpɛ na hwɛ sɛ mmara kwan so adwumakuw, beae a wɔyɛ nneɛma, adansedi krataa nɔma, kuw a wɔde ma, nna a wɔde di dwuma, dwumadi ahorow a wɔakata so ne nneɛma a ɛfa ho no yɛ nokware anaa.
TÜV SÜD CE adansedi krataa krataa nhwɛso
TÜV SÜD ISO 13485 abodin krataa krataa nhwɛso
Spine FSC krataa nhwɛso
ISO 13485 abodin krataa krataa nhwɛso
Wɔde nkrataa mfonini ahorow kyerɛ sɛnea ɛbɛyɛ a wobetumi de ahwɛ nkutoo na ɛnsɛ sɛ wobu no sɛ adanse a ɛkyerɛ sɛ wɔama ade biara ho kwan wɔ gua biara so.
3Hwɛ raw-material ne production traceability mu
Nnompe a wɔde hyɛ nipadua mu a wɔbɛtɔ no hwehwɛ pii sen sɛ wobesi nneɛma a wɔde ahyɛ mu no so dua wɔ nhoma a wɔahyehyɛ mu. Bisa nea ɔyɛe no sɛ ɔnkyerɛ sɛnea wobetumi ahwehwɛ ade a wɔde ahyɛ nipadua mu a wɔawie no mu denam mfiri, ɔhyew a wɔde sa yare anaa nea wɔde yɛ adwuma wɔ soro, nhwehwɛmu ne nneɛma a wɔde ahyɛ mu ho kyerɛwtohɔ a ɛba no so.
Ɛsɛ sɛ traceability nhwɛsoɔ a mfasoɔ wɔ so de finished-product lot anaa serial identifier no bata raw-material certificate, production traveller, key process records ne inspection a ɛtwa toɔ no ho. Sɔhwɛ ne gyinapɛn pɔtee no gyina afiri no, nneɛma a wɔde yɛ, sɛnea wɔpɛ sɛ wɔde bedi dwuma ne gua so; kwati sɛ wode nhwehwɛmu kratasin a wɔde di dwuma wɔ ɔkwan a ɛkɔ akyiri so bedi dwuma wɔ abusua biara a wɔde bɛhyɛ nipadua mu no ho.
- Bisa nhwɛsode batch kyerɛwtohɔ a wɔayɛ mu nsakrae ma ade a wɔde toto ho.
- Hwɛ sɛnea wɔkyerɛ nneɛma a ɛne ne ho nhyia, wɔtetew mu na wɔde si hɔ.
- Bisa sɛnea akwan titiriw a wɔde ma afoforo no da so ara yɛ nea wotumi hwehwɛ.
- Si bere tenten a wɔde sie kyerɛwtohɔ ahorow a ɛyɛ papa ma gua a ɛfa ho no so dua.
XC Medico no ɔmanfoɔ wobetumi de orthopedic implant quality-control overview adi dwuma sɛ mfiase ama nkɔmmɔbɔ, nanso ɛsɛ sɛ adetɔfo da so ara bisa adanse a ɛfa ade ne lot pɔtee bi ho bere a ɔrefata no.
4Hwehwɛ design validation, process validation ne sɔhwɛ mu
Bisa adanse bɛn na ɛfoa nhyehyɛe pɔtee a wode bɛhyɛ nipadua mu a woayɛ w’adwene sɛ wobɛtɔ no so. Ebia sɔhwɛ amanneɛbɔ a ɛfa ne kɛse, nneɛma anaa nhyehyɛe soronko ho no nyɛ ananmusifo. Ɛsɛ sɛ nea ɔyɛ no tumi kyerɛkyerɛ sɛnea wɔpaw nhyehyɛe a wɔasɔ ahwɛ no ne sɛnea nea efii mu bae no fa nneɛma abusua no nyinaa mu.
Ɛgyina adeɛ no so no, nhwehwɛmu no betumi ayɛ nneɛma a wɔde yɛ adwini, asiane ho dwumadie, nsusuiɛ nhwehwɛmu, mfiri sɔhwɛ, biocompatibility, ahotew, nneɛma a wɔde kyekyere, sterilization anaa special-process validation. Ɛsɛ sɛ wo su pa ne mmarahyɛ akuw no kyerɛkyerɛ kyerɛwtohɔ ahorow a ɛho hia ma gua a wɔde wɔn ani asi so ne sɛnea wɔabɔ wɔn tirim sɛ wɔde bedi dwuma no mu.
Bere a worehwɛ adwumayɛbea bi mu no, fa akwan a wɔakyerɛw no toto nneɛma a wɔyɛ ankasa ho. XC Medico de ɔmanfoɔ nsɛm a ɛfa ne... nnompe mu nneɛma a wɔde hyɛ nipadua mu a wɔyɛ ; ɛsɛ sɛ wɔn a wɔkyekyɛ nneɛma no de nsɛm a ɛte saa siesie akontabuo ho nsɛmmisa pɔtee sen sɛ wɔbɛfa wɛbsaet nkyerɛkyerɛmu bi sɛ akontabuo ho adanseɛ.
5Hwɛ sɛnea nneɛma a wɔde yɛ adwuma, nnwinnade ne nhyehyɛe no nyinaa di mũ
Katalog a ɛtrɛw ho wɔ mfaso bere a nhyehyɛe ahorow a w’atɔfo hia no awie, wɔakyerɛw ho asɛm bere nyinaa na ɛwɔ hɔ ankasa nkutoo. Hwɛ nneɛma a wɔde hyɛ nipadua mu, nnwinnade, trays, cases, spare parts, size ranges ne replenishment nneɛma mu sɛ nhyehyɛe biako.
- Si so dua sɛ SKU ahorow bɛn na ɛyɛ gyinapɛn, wɔayɛ no sɛnea wɔkra anaasɛ wɔretu afi hɔ nkakrankakra.
- Hwɛ sɛ nnwinnade ne nneɛma a wɔde hyɛ nipadua mu a ɛsono emu biara ne nhyehyɛe koro a wɔakyerɛw ho asɛm no hyia anaa.
- Hwɛ labeling, akwankyerɛ a ɛfa sɛnea wɔde bedi dwuma ne packaging nhyehyɛe sɛnea gua te.
- Bisa sɛnea wɔka nsakrae a ɛba wɔ nhyehyɛe mu ne nneɛma a wɔagyae mu no ho asɛm.
- Si so dua sɛ wɔakyerɛw nsɛm a ɛne ne ho hyia na ɛwɔ nkabom a wɔagye atom nkutoo.
Nnye nsɛm a ɛtrɛw te sɛ 'ɛne nhyehyɛe nyinaa hyia' anaa 'MRI ahobammɔ' a enni mfiri pɔtee bi ho nkyerɛwde ne adanse a ɛfoa so. Ɛsɛ sɛ wɔhwehwɛ sɛnea ɛne ne ho hyia ne MR ahobammɔ ho nsɛm hwɛ ma aduru no pɛpɛɛpɛ ne tebea horow a wɔahyɛ da ayɛ.
6Hwɛ sɛnea wɔyɛ nneɛma, nneɛma a wɔakora so ne sɛnea wɔde nneɛma kɔma
Ɛsɛ sɛ wɔde wo nkɔmhyɛ no toto tumi ho, na ɛnyɛ sɛ adwumayɛbea nɔma a egyina hɔ ma ne ho. Kyɛ SKU afrafra a ɛyɛ nokware, mpɛn dodow a wɔkra, tender nhyehyɛe ne botae som gyinabea. Afei bisa nea ɔyɛ no sɛ ɔnkyerɛkyerɛ tumi a ɛwɔ hɔ, bottleneck akwan, inventory policy ne lead-time assumptions mu.
Hwɛ nsonsonoe a ɛda nneɛma a ɛwɔ stock mu, standard production ne customized nneɛma ntam. Bisa sɛnea wɔhwɛ nneɛma a wɔde yɛ nneɛma a ɛho yɛ na, akwan a wɔde ma afoforo, nnwinnade a wɔhwɛ so ne nea wɔhwehwɛ no dodow a ɛkɔ soro no ho dwuma. Nnansa yi nsɛm a wɔde mena bere ano a ɛfa nneɛma a wɔkra a wɔde toto ho no ho wɔ mfaso kɛse sen bɔhyɛ a wɔde ma wɔ ɔkwan a ɛkɔ akyiri so sɛ wɔde nneɛma bɛmena ntɛmntɛm.
XC Medico deɛ no implant supply-chain ne warehousing overview kyerɛkyerɛ ne ɔmanfo nhyehyɛe gyinabea mu. Ɛsɛ sɛ obi a ɔkyekyɛ nneɛma di akyi de mprempren a ɛwɔ hɔ ho mfonini ne bere a wɔakyerɛw ama nhyehyɛe ahorow pɔtee a wɔresusuw ho no di akyi.
7Ma OEM / ODM, MOQ ne adwene-agyapade nsɛm mu da hɔ
Private-label ne customized projects hwehwɛ gyinaesi ahorow a ɛnyɛ unit bo bi nka ho. Ansa na wobɛpene nhwɛsoɔ so no, kyerɛw nea ɔwɔ mfonini, nnwinnade, nokwaredi data, packaging artwork ne nea efi mu ba dinkyerɛw. Kyerɛkyerɛ sɛnea wɔbɔ kokoam nsɛm ho ban ne sɛ ebia wobetumi de mfonini ahorow ama adetɔfo afoforo anaa.
- Tetew standard private labeling fi nokware design customization ho.
- Kyerɛkyerɛ nhwɛsoɔ, validation ne production-approval stages mu.
- Kyerɛw dodow a wɔkra a ɛba fam koraa denam SKU ne nhyehyɛe a edi mũ so.
- Mopene so wɔ design-change notification ne revalidation asɛyɛde ahorow ho.
- Ma tooling wurayɛ, asasesin mu nsɛm ne hokwan ahorow a ɛwɔ sɛ wogyae adwuma no mu da hɔ.
Sɛ wopɛ aguadi mu nhwehwɛmu a emu dɔ a, fa eyi di dwuma OEM manufacturer due-diligence checklist ka wo su ne mmara mu nhwehwɛmu ho.
8Hwɛ sɛnea wɔkyerɛw wɔn din, tender ne technical-document mmoa
Ebia adwumakuw bi a ɔyɛ nneɛma a wogye tom na ɛda so ara yɛ nea ɛnyɛ papa sɛ ne nkrataa ntumi nkyerɛ sɛ wɔbɛkyerɛw wɔn din anaasɛ wɔbɛkyerɛw wɔn din wɔ wo gua so a. Yɛ document matrix ansa na wode aguadi krataa a edi kan no akɔ.
Ɛsɛ sɛ matrix no kyerɛ krataa biara a wɔhwehwɛ, owura, kasa, ɔkwan a wɔfa so yɛ, nsakrae, da a wɔhwɛ kwan sɛ wɔde bɛma ne kokoam tebea. Hwɛ sɛnea nea ɔyɛe no di updates so bere a adansedi krataa, label, akwankyerɛ, nkyerɛkyerɛmu anaa nhyehyɛe bi sesa no.
Bisa nkrataa a wɔde ahyɛ gua pɔtee bi mu
Sɛ anka wubebisa sɛ, 'So wowɔ CE anaa FDA?', fa ɔman a wode w'ani asi so, nneɛma abusua ne nhwɛsode a wɔahyehyɛ no ma. Bisa nea ɔyɛ no sɛ ɔmfa SKU biara ho mfonini nkyerɛ mmara ne mfiridwuma ho adanse a ɛwɔ hɔ no. Ma mmarahyɛ baguafo a wɔfata nhwɛ sɛ nkrataa no dɔɔso ma gua a wopɛ sɛ wotɔn no.
9Hwɛ anwiinwii ho dwumadie, CAPA ne ahoboa a wɔde bɛkae
Ɛsɛ sɛ Supplier qualification ka nea ɛba bere a wɔde amena akyi. Bisa sɛnea wogye anwiinwii, wɔhwehwɛ mu, wɔhwehwɛ mu, wɔde kɔ so na wɔto mu. Si sɛnea nea ɔyɛ no de nsɛm a ebetumi aba sɛ wɔbɛbɔ ho amanneɛ, afuw mu nneyɛe, nkae ne nteɛso nneyɛe kyerɛ wɔn a wɔkyekyɛ ne sikasɛm mu adwumayɛfo afoforo no so dua.
- Hena na ɔyɛ anwiinwii ne n’ani a wɔde di nkitaho titiriw?
- Nsɛm bɛn na ɛho hia na wɔatumi afi nhwehwɛmu ase?
- Ɔkwan bɛn so na wɔhwɛ nneɛma a wɔsan de ba no so na wɔhwehwɛ mu?
- Ɔkwan bɛn so na wɔkyerɛw nea ɛde ba no ntini, CAPA ne sɛnea ɛyɛ adwuma yiye nhwehwɛmu?
- Ɔkwan bɛn so na wohu lot ne adetɔfo a ɛka wɔn bere a wɔreyɛ afuw mu adeyɛ bi no?
Mfa wo ho nto 'mfiridwuma mmoa' a ɛnyɛ ɔkwan pa so sɛ nea wode besi gua akyi nhyehyɛe a wɔakyerɛw ne mmara kwan so asɛyɛde ahorow a wɔakyekyɛ no pefee ananmu.
10Fa controlled sample order ne supplier scorecard di dwuma
Nhwɛsode a wɔkra no sɔ pii hwɛ sen sɛnea nneɛma no te. Fa di dwuma de susuw nsɛm a wɔafa aka no pɛpɛɛpɛ, nkrataa sohwɛ, nkyerɛwde, nneɛma a wɔde kyekyere, nkitahodi, bere a wɔde di dwuma, nea efi nhwehwɛmu mu ba ne mmuae a wɔde ma wɔ nsɛmmisa ho. Kyerɛw nneɛma a wɔde gye tom ansa na wɔahyɛ nhwɛsode no.
Fa gyinapɛn koro no ara a wɔakari no bɔ nea ɔyɛ no mu biara nkontaa. Nkonimdi krataa a wɔtaa de di dwuma no betumi ayɛ mmara a ɛfata, adanse a ɛyɛ papa, nea wotumi hwehwɛ mu, mfiridwuma mu tumi, nhyehyɛe a edi mũ, nneɛma a wɔde ma ho ahotoso, nkrataa, aguadi ho nsɛm ne mmoa. Fa bo sɛ ade biako mmom sen sɛ wobɛfa no ade titiriw.
| Category | Suggested weight | Nhwɛsoɔ a ɛfa nkontabuo ho asɛmmisa |
|---|---|---|
| Mmara ne quality-system fit | 25% na ɛwɔ hɔ. | So adanse a wɔagye atom no ka mmara kwan so adwumakuw, beae, nneɛma a wɔyɛ ne gua a wɔde wɔn ani asi so no ho asɛm? |
| Traceability ne validation | 20% na ɛwɔ hɔ. | So nea ɔde nneɛma ma no betumi de nneɛma a wɔka ho asɛm no abata kyerɛwtohɔ ahorow a wɔahyɛ so ho? |
| Product ne adwinnade a edi mũ | 15% na ɛwɔ hɔ. | So nhyehyɛe a wɔhwehwɛ no di mũ, wɔakyerɛw ho asɛm na wotumi boa? |
| Tumi ne nneɛma a wɔde ma | 15% na ɛwɔ hɔ. | So tumi, nneɛma a wɔakora so ne bere a wɔde di kan ho nsɛm a wɔka no, mprempren data na ɛfoa so? |
| Nwoma ne mmoa a wɔde ma wɔ gua akyi | 15% na ɛwɔ hɔ. | So nea ɔde nneɛma ma no betumi aboa dinkyerɛw, tender, anwiinwii ne nsakrae sohwɛ? |
| Aguadi mu nea ɛfata | 10% na ɛwɔ hɔ. | So bo, MOQ, akatua, IP ne asasesin mu nsɛm yɛ nea ɛbɛkɔ so atra hɔ? |
Siesie nneɛma a emu duru no ma ɛne wo gua ne asiane a ɛwɔ wo nneɛma mu no hyia. Ɛsɛ sɛ wɔfa mmara, su pa anaa traceability huammɔdi biara a ɛho hia sɛ ɔpon, ɛnyɛ sɛ wɔde bo a ɛba fam anaa nkontaa a ɛkorɔn wɔ baabi foforo tua ho ka.
Frɛko kɔkɔɔ a wɔtaa de di dwuma bere a wɔrepaw obi a ɔyɛ nneɛma a wɔde bɛhyɛ nipadua mu no
Nsɛm a wɔka a ɛnyɛ nea ɛkɔ akyiri
Ɔyɛfoɔ no ka sɛ 'FDA, CE ne ISO adansedie' nanso ɔrentumi mfa asɛm no nkɔka mmara kwan so adwumakuo, adeɛ, mfonini ne gua no ho.
Nwoma a wɔrentumi nhwɛ sɛ ɛyɛ nokware
Adansedie nɔma, akuo a wɔde ma, nna anaa nneɛma a wɔakata so no nni hɔ, ɛnhyia anaasɛ enni hɔ mma ahofadie mu adansedie.
Bo ansa na wɔahwehwɛ
Wɔde firm quotation ma ansa na nea ɔyɛe no asi nneɛma nhyehyɛe, nneɛma a wɔde kyekyere, nkrataa ne dinkyerɛw ahiade so dua.
Generic sɔhwɛ amanneɛbɔ ahorow
Amanneɛbɔ nkyerɛ nhwɛsoɔ a wɔasɔ ahwɛ, nhyehyeɛ, ɔkwan, gyinapɛn a wɔde gye tom anaa abusuabɔ a ɛda adeɛ a wɔabisa no ntam.
Nea ɔyɛe no ho nkyerɛkyerɛmu a emu nna hɔ
Edin ahorow a ɛwɔ apam no so, adansedi krataa, nkyerɛwde, sika a wɔde tua ho ka ne sikakorabea akontaabu no gu ahorow a nkyerɛkyerɛmu a wɔakyerɛw ato hɔ biara nni ho.
Adeyɛ biara nni hɔ a wɔyɛ wɔ gua akyi
Mmoa gyina ankorankoro adetɔn nkitahodi so sen anwiinwii a wɔakyerɛw, CAPA, ani a wɔma ɛda hɔ ne akwan a wɔfa so kae nneɛma.
Sɛnea wɔde XC Medico toto wɔn a wɔyɛ nneɛma afoforo ho
Fa nhwehwɛmu kratasin koro no ara di dwuma wɔ XC Medico ne adwumakuw foforo biara a wɔapaw no tiawa no so. Ɔmanfoɔ adwumayɛbea, quality-control ne supply-chain nkratafa bɛtumi aboa wo ma woasiesie nsɛmmisa, nanso ɛsɛ sɛ supplier approval gyina mprempren nkrataa ne adanseɛ a ɛfa wo nneɛma ne gua ho so.
Anamɔn a edi hɔ a mfaso wɔ so ne sɛ wubesiesie wo botae-ɔman din, nneɛma nhyehyɛe a wɔhwehwɛ, akontaabu nhyehyɛe, OEM ahwehwɛde ne nkrataa matrix. Bisa obiara a ɔyɛ nneɛma no ma ɔmmua wɔ ɔkwan koro no ara so. Eyi ma wonya kyerɛwtohɔ a wɔde toto ho wɔ nea ɛyɛ papa, mmara ne aguadi mu nhwehwɛmu ho.
XC Medico adwumakuw ne adwinnan ho nsɛm. Fa video no siesie nsɛmmisa a wode bedi akyi; wie adetɔnfo pene a wɔde mprempren nkrataa a wɔahyɛ so ne akontaabu ho adanse di dwuma.
Sɛ w’ahyehyɛde no resesa obi a ɔde nneɛma ma dedaw a, hwɛ asiane ahorow a ɛwɔ adwumayɛ mu a wɔaka ho asɛm wɔ akwankyerɛ a ɛfa wɔn a wɔde nnompe a wɔde hyɛ nipadua mu ma a wɔbɛsakra wɔn a wɔrensɛe nnompe a wɔkyekyɛ no.
Nsɛm a wɔtaa bisa
Adansedi nkrataa bɛn na ɛsɛ sɛ obi a ɔyɛ nnompe a wɔde hyɛ nipadua mu no nya?
Mmuae no gyina ade a wɔyɛ ne gua a wɔde wɔn ani asi so no so. ISO 13485 yɛ gyinapɛn a wogye tom kɛse a ɛfa nneɛma pa ho nhyehyɛe ho ma nnuruyɛ-mfiri ahyehyɛde ahorow, nanso ɛsɛ sɛ adetɔfo nso hwɛ adanse a ɛfa nneɛma pɔtee bi ho a ɛfa mmara ho. Hwɛ adansedi krataa no kɛse, beae, mmara kwan so adwumakuw, nneɛma abusua, mprempren tebea ne gua so ahwehwɛde ahorow a ɛfata.
So FDA din a wɔkyerɛw no kyerɛ sɛ wɔapene so sɛ wɔde nipadua no bɛhyɛ nipadua mu?
Dabi FDA ka sɛ adwumayɛbea no dinkyerɛw ne mfiri a wɔakyerɛw din nkyerɛ sɛ wɔapene so, wɔagye atom anaasɛ wɔama ho kwan wɔ adwumayɛbea no anaa ne mfiri ahorow no ho. Baabi a ɛhia sɛ mfiri bi hwɛ mu ansa na wɔatɔn no, hwɛ sɛ wɔagye atom, wɔapene so anaa tumi krataa foforɔ a ɛfata no wɔ ɔkwan soronko so.
Ɔkwan bɛn so na obi a ɔkyekyɛ nneɛma betumi ahwɛ sɛ ISO 13485 adansedi krataa no yɛ nokware?
Hwɛ adansedi krataa nɔma, mmara kwan so adwumakuw, beae no address, dwumadi ahorow a wɔakata so, nneɛma a wɔyɛ, adansedi kuw ne nna a wɔde di dwuma. Fa adansedie krataa no si adansedie krataa no so ne adwumakuo a ɛde ma anaa adansedie krataa no wɔ baabi a ɛbɛyɛ yie, na hwɛ sɛ wɔde nhyehyɛeɛ a ɛyɛ papa no adi dwuma wɔ nneyɛeɛ mu wɔ nkrataa mu nhwehwɛmu anaa akontabuo mu.
Nwoma bɛn na ɛsɛ sɛ wɔhwehwɛ mu ansa na wɔakra?
Adanse a ɛtaa ba no bi ne adwumakuo ne beaeɛ a wɔyɛ nneɛma ho nsɛm, ISO 13485 kɛseɛ, gua so nkrataa pɔtee, nneɛma ne batch traceability nhwɛsoɔ, adanseɛ a ɛfa validation anaa sɔhwɛ ho, labeling, akwankyerɛ, nneɛma a wɔde ma ho nsɛm, anwiinwii akwan ne nsakraeɛ-hwɛ asɛdeɛ. Ɛsɛ sɛ adwumayɛfo a wɔfata a wɔyɛ adwuma wɔ nneɛma pa ne mmara so na wɔhyehyɛ din pɔtee no.
Nsonsonoe bɛn na ɛda obi a ɔyɛ nneɛma a wɔde hyɛ nipadua mu ne nea ɔde ma ntam?
Ɔyɛfo bi yɛ nneɛma a wɔyɛ anaa ɔhwɛ so na obetumi nso akura adwini ne mmara ho asɛyɛde ahorow. Obi a ɔde nneɛma ma no betumi ayɛ nea ɔyɛ, brand wura, nea ɔkyekyɛ anaa aguadi adwumakuw. Ɛsɛ sɛ adetɔfo hu adwumakuw biara dwumadi a wɔakyerɛw ho asɛm sen sɛ wɔde wɔn ho bɛto aguadi ho nkyerɛkyerɛmu no nkutoo so.
So ɛsɛ sɛ bo yɛ ade titiriw a wɔde gyina so bere a wɔrepaw nea ɔyɛ no?
Dabi Ɛsɛ sɛ wɔde mmara a ɛfata, adanse a ɛkyerɛ sɛ ɛyɛ papa, nea wotumi hwehwɛ, nneɛma a wɔyɛ no nyinaa, tumi, ahotoso a wɔde bɛkɔ, nkrataa, mmoa a wɔde ma wɔ gua akyi ne apam mu nsɛm bom hwɛ bo. Mfitiaseɛ bo a ɛba fam betumi ama wɔabɔ ka kɛse wɔ dinkyerɛw, nneɛma a wɔakora so anaa nea ɛyɛ papa ho akyiri yi.
Bisa manufacturer validation pack mma
Kyɛ wo botae gua, ade kuw, hwɛ kwan sɛ wobɛkra nhyehyɛe ne OEM ahwehwɛde. Bisa nkrataa a wɔde ahyɛ mu a wo quality, regulatory ne procurement teams betumi ahwɛ mu ansa na woatu akɔ samples anaa aguadi order so.
Wo ne XC Medico nkasaAban mmara kwan so nsɛm a wɔde gyina hɔ ma
Adwumayɛfoɔ a wɔde di dwuma ho amanneɛbɔ: Wɔayɛ asɛm yi sɛ ɛbɛboa adwuma-ne-adwumayɛfoɔ a wɔde nneɛma ma no nhwehwɛmu a ɛfata. Ɛnyɛ ayaresabea afotu, mmara mu afotu anaasɛ gyinaesi a ɛkyerɛ sɛ wɔama aduru pɔtee biara ho kwan ama gua pɔtee bi. Mmara ne su pa ahwehwɛde ahorow gu ahorow wɔ mfiri, sɛnea wɔpɛ sɛ wɔde di dwuma ne tumidi mu; bisa adwumayɛfo a wɔfata ansa na woasi gyinae sɛ wobɛpene so anaasɛ wobɛtɔ ade.
