Aduruyɛ mfiri sourcing · Adetɔfo akwankyerɛ a mfaso wɔ so
Sɛ wɔbɛhwehwɛ wɔn a wɔyɛ mfiri a wɔde yɛ oprehyɛn mu a, ɛhwehwɛ pii sen sɛ wɔde katalog kɛse ne ne bo a wɔde bɛtoto ho. Nhwehwɛmu a wotumi de ho to so hwehwɛ nea ɔyɛ no mmara kwan so nipasu, nhyehyɛe a ɛyɛ papa, mmara tebea a ɛfa nneɛma pɔtee bi ho, nneɛma a wɔde yɛ, sɛnea wɔhwɛ nneɛma so, sɛnea wotumi hwehwɛ, nhwɛsode, sɛnea wɔde nneɛma kɔma no, ne mmoa a wɔde ma wɔ gua akyi. Saa nhwehwɛmu kratasin a ɛwɔ nsɛntitiriw 12 yi dan saa ahwehwɛde ahorow no ma ɛbɛyɛ ɔkwan a wɔfa so paw wɔn a wɔde nneɛma ma no mpɛn pii.
Wobɛyɛ Dɛn asusuw Oprehyɛn Adwinnade a Wɔyɛ Ho?
Fi ase denam nea ɔde di dwuma no ahwehwɛde ho nkyerɛkyerɛmu a wɔakyerɛw so, afei susuw obiara a ɔpɛ sɛ ɔyɛ ɔkannifo no ho wɔ akwan anan so: nkrataa mu nhwehwɛmu, mfiridwuma ho nkɔmmɔbɔ, nhwɛsode sɔhwɛ, ne —baabi a asiane ma ɛfata —akwankyerɛ a wɔyɛ wɔ akyirikyiri anaa beae hɔ. Mfa adansedi krataa PDF, wɛbsaet so asɛm, anaa nhwɛsode a wotumi hu nkutoo so nnye adetɔnfo bi ntom.
Mmuae tiawa a eye sen biara: paw nea ɔyɛe a ɔde adanse a emu yɛ den a wotumi di ho adanse ma wɔ wo mfiri pɔtee ne gua no ho —ɛnyɛ adwumakuw a ɛwɔ nneɛma a wɔakyerɛw a ɛware sen biara anaasɛ nea wɔabɔ ho ka a ɛba fam sen biara no.
Kyerɛkyerɛ W’ahwehwɛde ahorow mu Ansa na Woakɔ Wɔn a Wɔde Nneɛma Ma no nkyɛn
Obi a ɔde nneɛma ma no ntumi mfa nsɛm a wɔafa aka anaasɛ nea wɔde di mmara so a ntease wom mma kosi sɛ wɔbɛkyerɛkyerɛ ade a wɔpɛ sɛ wɔyɛ no mu pefee. Siesie ahwehwɛde ho krataa a ɛyɛ tiawa ansa na woayɛ list tiawa.
- Mfiri ne sɛnea wɔpɛ sɛ wɔde di dwuma: adwinnade din, ɔkwan a wɔfa so yɛ, tebea a wotumi de di dwuma bio anaasɛ wɔde di dwuma pɛnkoro, ne sɛ ebia wɔde ma nkutoo anaasɛ sɛ ɛyɛ nhyehyɛe a wɔde hyɛ nipadua mu no fã.
- Guadi a wɔde wɔn ani asi so: aman a wɔtɔn, mfiri nkyekyɛmu, ɔkwan a wɔfa so kyerɛw wɔn din a ɛfata, kasa, nkyerɛwde a wɔde kyerɛw, ne nea wɔde ba amannɔne anaa nea wɔama ho kwan-ananmusifo ahwehwɛde ahorow.
- Mfiridwuma ho nkyerɛkyerɛmu: nsusuwii, abodwokyɛre, nneɛma grade, hardness, surface finish, interface geometry, mfonini ahorow, ne sɔhwɛ akwan.
- Dwumadie: ahotew tebea, passivation, packaging, sterilization tebea, sterilization compatibility, ne validated reprocessing akwankyerɛ wɔ baabi a ɛfata.
- Aguadi mu kɛse: nkɔmhyɛ dodow, mfitiase nhyehyɛe, bere a wɔde asi wɔn ani so, nneɛma a wɔde kyekyere nneɛma nhyehyɛe, kokoam nkyerɛwde, ne nkrataa a wɔhwehwɛ.
Nhwehwɛmu a wɔyɛ wɔ adwinnan bi de nnompe mu nneɛma akuw betumi aboa ma wɔahu sɛ ebia nea wɔyɛ no daa no ne nea wɔayɛ ho nhyehyɛe sɛ wɔbɛtɔ no hyia anaa. Nanso, catalog trɛw nkutoo nkyerɛ sɛ ɛfata ma mfiri biara a wɔakyerɛw din.
12-Point Checklist a Wɔde Ma Wɔn a Wɔyɛ Oprehyɛn Nnwinnade
- Si mmara kwan so yɛfo ne beae no asɛyɛde ahorow so dua Kyerɛ onii a ɔwɔ mfiri no nhyehyɛe, onii a ɔyɛ emu biara, nea ɔyɛ nneɛma a wɔde wie ne nea wɔde kyekyere nneɛma, ne nea oyi ade a wɔawie no adi. Kyerɛw address ahorow ne akwan a ɛho hia a wɔde ma afoforo.
- Hwɛ nhyehyɛe a wɔde hwɛ nneɛma pa so Bisa mprempren ISO 13485 adansedi krataa no na hwɛ ahyehyɛde no din, address a wɔde yɛ, adansedi no kɛse, adansedi kuw a ɛde ma, tumi krataa, adansedi krataa no tebea, ne da a ɛbɛba awiei.
- Hwɛ sɛ gua so tumi krataa a ɛfa afiri pɔtee bi ho no yɛ nokware Fa afiri pɔtee, ne mfonini, nea wɔpɛ sɛ wɔde di dwuma, nkyekyɛmu, ne mmara kwan so yɛfo no hyia nkrataa a wɔhwehwɛ wɔ gua biara a wɔrekɔ no mu. Adwumakuw no din a wɔkyerɛw ne nneɛma a wɔma ho kwan anaasɛ wɔpene so nyɛ ade koro.
- Hwɛ nneɛma ne wɔn a wɔde nneɛma ma no sohwɛ Hwehwɛ nneɛma ho nkyerɛkyerɛmu ne adansedi nkrataa, nneɛma a wɔde ma no sohwɛ a wɔapene so, nhwehwɛmu a ɛba, lot mu mpaapaemu, ne ɔkwan a wɔfa so di nneɛma a wɔde besi ananmu anaa nneɛma a wɔsakra no ho dwuma.
- Hwɛ tumi a wɔde yɛ nneɛma Si so dua sɛ mfiri, forging, ɔhyew ayaresa, welding, polishing, passivation, coating, assembly, ne inspection tumi ne ade no hyia. Hwɛ anammɔn a wɔde ma afoforo ne sɛnea wodi so.
- Hwehwɛ nhyehyeɛ no mu adansedie ne nsusuiɛ mu Bisa sɛdeɛ wɔgye akwan titire no tom ne sɛdeɛ wɔsɔ nhwehwɛmu, torque, dimensional, anyinam ahoɔden, ne susudua mfiri foforɔ kari na wɔhwɛ so.
- Sɔ traceability ne document control hwɛ Paw sample lot na bisa nea ɔyɛe no sɛ ɔnhwehwɛ mu nkɔ raw material, akwantufo anaa routing kyerɛwtohɔ, nhwehwɛmu, nea ɛnhyia, labeling, packaging, ne release approval.
- Hwɛ mfiridwuma mu adwumayɛ ne dwumadie a wɔpene so pene nhwɛsoɔ so de toto mfonini ne dwumadie-asɛm te sɛ fit, alignment, grip, cutting performance, torque transmission, interface compatibility, ergonomics, ne repeated processing.
- Hwɛ asɛyɛde ahorow a ɛfa ahotew, nneɛma a wɔde kyekyere nneɛma ho, ne nea wɔde sterilization ho Ma mu da hɔ sɛ ebia wɔde mfiri ahorow no ma a ɛnyɛ nea wɔde nnuru a ekum mmoawa anaa nea wɔmfa nnuru nni dwuma wom, ɔfã bɛn na ɛgye ahotew ne sterilization tom, ne nneɛma a wɔde kyekyere nneɛma no mudi mu kura, bere a wɔde sie, bioadesoa, ne adanse a ɛkyerɛ sɛ wɔde nneɛma gu mu no fa ho.
- Hwɛ nhyehyeɛ ne customization controls Sɛ wopɛ OEM/ODM adwuma a, hwɛ design inputs, asiane ho dwumadie, mfonini, nokwaredi, validation, adwene mu agyapadeɛ, nhwɛsoɔ a wɔpene so, design transfer, ne nsakraeɛ-control asɛdeɛ.
- Susuw tumi ne ahotoso a wɔde bɛma Hwɛ bere a wɔde di dwuma ankasa, tumi anohyeto ahorow, dodow a ɛba fam koraa a wɔkra, ahobammɔ a wɔde asie, nkɔmhyɛ a wɔde bedi dwuma, ahyɛde a wosi so dua, nneɛma a wɔde ahyɛ mu pɛpɛɛpɛ, nkrataa a wɔde kɔ amannɔne, ne nhyehyɛe a wɔayɛ sɛ wɔbɛsan agye no sɛ ebia ɛkyɛ anaa.
- Hwɛ anwiinwii, CAPA, warranty, ne nea ɛkɔ so no Si anwiinwii a ɛkɔ soro, nea ɛde ba no mu nhwehwɛmu, nteɛso ne nea wɔde siw ano, afuw mu adeyɛ anaa mmoa a wɔde bɛkae, nneɛma a wɔde siesie, nsiesie, warranty nsɛm, ne adwumayɛ a ɛkɔ so no so dua.
Sɛnea Wɔbɛhwɛ sɛ Nsɛm a Wɔka Kyerɛ sɛ Ɛyɛ Pa ne Mmarahyɛ Bagua
ISO 13485 yɛ quality-system gyinapɛn
ISO 13485 kyerɛ nhyehyɛe a ɛfa nneɛma pa ho a wɔhwehwɛ ma ahyehyɛde ahorow a wɔde wɔn ho hyɛ aduruyɛ-mfiri asetra mu. Ɛyɛ adanse a ntease wom bere a adansedi krataa no yɛ adwuma na ne kɛse fa ahyehyɛde, beae, ne dwumadi ahorow a ɛfa ho no ho. Ɛnkyerɛ sɛ, ɛno ankasa nkyerɛ sɛ wɔakyerɛw nneɛma biara a ɛwɔ nhoma a wɔahyehyɛ mu, ɛfata wɔ ayaresabea, anaasɛ wɔama ho kwan wɔ wo gua so.
Bisa adansedi krataa a edi mũ no sen sɛ wobɛma ahyɛnsode a wɔatwitwa. Fa adansedi kuw no anaa ne ɔmanfo database no hwɛ sɛ ɛyɛ nokware wɔ baabi a ɛbɛyɛ yiye, na fa adwumakuw no din ne address toto nsɛm a wɔafa aka, sika a wɔde tua ho ka, mpaemuka, nkyerɛwde, ne nneɛma ho kyerɛwtohɔ ho.
Ɛsɛ sɛ CE agyiraehyɛde no ne afiri no ne EU MDR kwan no hyia
Wɔ Europa Aman Nkabom no fam no, kyerɛ mfiri no nkyekyem ne ɔkwan a ɛfata a wɔfa so hwehwɛ sɛnea ɛne ne ho hyia wɔ Aduruyɛ Mfiri Mmara no ase. Hwɛ EU Mpaemuka a Ɛfa Mmara a Ɛfa Nsɛm Ho no mu na sɛ adesuakuw no hwehwɛ sɛ kuw a wɔabɔ wɔn amanneɛ no de wɔn ho hyɛ mu a, adansedi krataa a ɛfata ne kuw a wɔabɔ wɔn amanneɛ no ho nsɛm. Si so dua sɛ afiri no abusua, mmara kwan so yɛfo, Basic UDI-DI baabi a ɛfata, atirimpɔw a wɔahyɛ da ayɛ, ne adansedi krataa no kɛse hyia.
FDA nhyehyɛe a wɔde kyerɛw wɔn din no nyɛ FDA pene
FDA ka no pefee sɛ establishment registration ne device listing nkyerɛ sɛ wɔapene so, wɔagye atom, anaa wɔama ho kwan. Wɔ United States fam no, hwɛ mfiri no nkyekyɛmu ne sɛ ebia mfiri no pɛpɛɛpɛ hia 510(k) tumi krataa, PMA pene, De Novo tumi krataa, anaasɛ wɔayi afi mu. Hwɛ sɛ database kyerɛwtohɔ a ɛfa ho no yɛ nokware sen sɛ wode wo ho bɛto 'FDA registered' badge so.
| Kyerɛw anaa ka | Nea ɛsɛ sɛ wodi ho adanse | Nea ɛnyɛ ɛno nkutoo na ɛkyerɛ |
|---|---|---|
| ISO 13485 adansedi krataa | Mmara kwan so din, beae, baabi a wɔyɛ, nea ɔde mae, nea ogye tom, tebea, ne bere a etwa to. | Aguade pɔtee bi ho tumi krataa a wɔde ma wɔ gua so anaasɛ ayaresabea a ɛfata. |
| CE agyiraehyɛde / EU nkrataa | Mfiri no ho nkyerɛkyerɛmu, nkyekyɛmu, mpaemuka, nipadua a wɔabɔ amanneɛ wɔ baabi a ɛfata, ne MDR a wɔde tua ho ka. | Tumi a wɔde ma a ɛnyɛ Europa nhyehyɛe a ɛwɔ hɔ no. |
| FDA dinkyerɛw/kyerɛwtohɔ | Mprempren nhyehyɛe ne listing data ne afiri no mmara kwan a ɛfata. | FDA pene, clearance, tumi krataa, anaa ahofadi a wɔde gyina akyi. |
| Sɔhwɛ amanneɛbɔ | Lab a wɔagye atom wɔ baabi a ɛfata, nhwɛsode a wɔde kyerɛ, ɔkwan a wɔfa so gye tom, da a wɔde gye tom, da, ne nea efii mu bae. | Sɛ production lot biara ne sample a wɔasɔ ahwɛ no yɛ pɛ. |
| Adansedie krataa a ɛkyerɛ sɛ wɔayɛ nhwehwɛmu/a ɛne ne ho hyia | Lot-specific data, specification, nea efi mu ba, release tumidi, ne traceable identifiers. | Nneɛma pa nhyehyɛe no nyinaa a etu mpɔn a kyerɛwtohɔ ahorow a ɛfoa so nni mu. |
Dɛn na Ɛsɛ sɛ Wohwɛ Bere a Woreyɛ Adwumayɛbea anaa Nneɛma a Ɛyɛ Pa Ho Nhwehwɛmu?
Asiane na ɛkyerɛ sɛnea akontaabu no mu dɔ. Wobetumi afa nkrataa, video so akontaabu a wɔyɛ no tee, ne nhwɛsode nhwehwɛmu so asusuw adwinnade a asiane nnim a ɛyɛ gyinapɛn ho. Ebia adwinnade foforo a ɛne implant hyia, mfiri a ɛnyɛ ɔyare mmoawa, adeyɛ a ɛho hia a wɔde ma afoforo, anaa bere tenten kokoam-label nhyehyɛe betumi ama ɛfata sɛ wɔyɛ akontaabu wɔ beae hɔ na wɔma ɛyɛ nokware kɛse.
Akontaabu a mfaso wɔ so di ahyɛde anaa lot ankasa bi akyi denam adwumayɛbea no so. XC Medico deɛ no quality control ne inspection overview de nhwɛsoɔ ma wɔ akwan a wɔfa so yɛ adwuma no mmeaeɛ a adetɔfoɔ bɛtumi abisa sɛ wɔbɛhunu.
| Audit area | Adanse a ɛsɛ sɛ wobisa | Nhwɛsoɔ asɛmmisa |
|---|---|---|
| Nneɛma a ɛba | Wɔn a wɔde nneɛma ma a wɔapene so din, nneɛma ho adansedi krataa, nhwehwɛmu a wɔaba, ne kyerɛwtohɔ a ɛfa nnipa a wɔayi wɔn afi nnipa mu. | Ɔkwan bɛn so na wɔde nneɛma dodow no bata adwinnade a wɔawie no ho? |
| Nneɛma a wɔyɛ no sohwɛ | Adwuma ho akwankyerɛ, akwan a wɔfa so fa kwan ho kyerɛwtohɔ, akwan a wɔagye atom, adwumayɛfo a wɔfata, ne nhwehwɛmu a wɔyɛ wɔ adwuma no mu. | Ɔkwan bɛn so na wohu nneɛma a ɛtwetwe adwene na wosiw ano? |
| Nsusuwii a wɔde susuw nneɛma | Calibration tebea, ɔkwan a wɔfa so susuw, gauge tumi, ne nhwehwɛmu kyerɛwtohɔ. | So wobetumi asusuw sɛnea adwinnade no gyina ano no ho wɔ ɔkwan a wotumi de ho to so so? |
| Ade a ɛnyɛ nea ɛne ne ho nhyia | Ntetewmu, tumi a wɔde di dwuma, adwuma a wɔsan pene so, ne nneɛma a ɛkɔ so ho kyerɛwtohɔ. | Hena na obetumi apene deviation so, na so wɔbɔ adetɔfo no amanneɛ? |
| Sesa tumidi | Nsakraeɛ abakɔsɛm, nkɛntɛnsoɔ nhwehwɛmu, nokwaredi, nokwaredi, ne adetɔfoɔ amanneɛbɔ. | Nsakrae bɛn na ɛhwehwɛ sɛ wɔkyerɛw adetɔfo pene so? |
| Traceability a wotumi hwehwɛ mu | Lot anaa serial number kyerɛwtohɔ, akwantufo, labeling, packaging, ne release adanse. | So wobetumi ahu lot biako a wɔawie no wɔ afã abien no nyinaa? |
| Anwiinwii ne CAPA | Anwiinwii fael, akwan a wɔfa so de ntini ba, CAPA mmɔdenbɔ nhwehwɛmu, ne escalation mmara. | Ɔkwan bɛn so na wohu huammɔdi ahorow a ɛsan ba bio na wosiw ano? |
Sɛnea Wɔbɛma Oprehyɛn Nnwinnade Nhwɛsode Adi
Nhwɛsode a wɔayɛ no fɛfɛɛfɛ no nnɔɔso. Yɛ nhyehyɛe a wɔakyerɛw a ɛkyerɛ sɛnea wɔpene so a ɛkyerɛ sɛnea wɔabɔ wɔn tirim sɛ wɔde adwinnade no bedi dwuma ne asiane a ɛwɔ mu. Ɛsɛ sɛ nea ɔyɛ ne nea ɔtɔ no pene mfonini ahorow, nsakrae gyinabea, akwan a wɔfa so sɔ hwɛ, gyinapɛn ahorow a wɔde gye tom, nhwɛsode dodow, ne sɛnea nhwɛsode ahorow a wɔapene so no bɛyɛ nneɛma a wɔyɛ no wuranom.
- Identity: model, drawing revision, ɔfã, kɛseɛ, agyiraeɛhyɛdeɛ, lot, ne packaging nhyehyeɛ.
- Nsusuwii ne ntamgyinafo: nsusuwii a ɛho hia, aware afã horow, implant anaa screw a ɛne ne ho hyia, runout, alignment, ne tolerances.
- Nneɛma ne nea wɔde wie: grade, hardness, surface condition, corrosion resistance wɔ baabi a ɛfata, pasivation, coating, ne ahotew.
- Dwumadi: grip, ratchet engagement, twa anaa drilling suban, torque transmission, locking, gyae, ne wear.
- Nneɛma a wɔsan yɛ: ɛko tia ahotew ne sterilization kyinhyia a wɔahyɛ da ayɛ no, a nkwaa, lumens, agyiraehyɛde, nneɛma a wɔde kata so, ne nsa ka ho.
- Nneɛma a wɔde kyekyere ne nea wɔde hyɛ so: akontaabu, ahobammɔ, nkyerɛkyerɛmu, akwankyerɛ, kasa, UDI anaa lot data wɔ baabi a ɛfata, ne akwantuo mu ahoɔden a wɔde gyina ano.
Repeatability check: bere a wɔapene sika kɔkɔɔ nhwɛsode no so akyi no, fa gyinapɛn koro no ara hwɛ nhwɛsode ahorow a efi beae a edi kan a wɔyɛ no. Eyi boa ma wohu sɛ ebia nea ɔyɛe no betumi asan ayɛ adwini a wɔapene so no wɔ nsenia so anaa.
Evaluating OEM ne Amanne Adwinnade Tumi
Sɛnea wɔyɛ no sɛnea wɔpɛ no betumi akyerɛ ahyɛnsode bi a ɛwɔ tray a ɛwɔ hɔ dedaw so, nsa a wɔayɛ mu nsakrae, adwinnade a wɔahyira so ama biribi a wɔde hyɛ nipadua mu, anaa mfiri foforo koraa. Saa nnwuma yi mfa mmara anaa mfiridwuma mu asiane koro no ara mma. Ansa na wobɛkyɛ mfonini anaa nhwɛsoɔ no, kyerɛkyerɛ kokoamsɛm, adwini wurayɛ, akyi adwene mu agyapadeɛ a wɔama ho kwan, nnwinnadeɛ wurayɛ, ne kwan a wɔfa so nya kyerɛwtohɔ a ɛkyerɛ sɛ ɛyɛ nokware.
Sɛ wopɛ private-label anaa custom program a, hwɛ nea ɔyɛe no de orthopaedic OEM/ODM tumi na bisa hena na ɔwɔ design-control dwumadi biara. Ɛsɛ sɛ obi a otumi de nneɛma ma no kyerɛ nea ɔde di dwuma no ahiade ase kɔ nsɛm a wɔahyɛ da ayɛ ne nsakrae a wɔyɛ wɔ nkrataa mu mu —ɛnyɛ sɛ ɔde ne ho nto nkrasɛm a ɛnyɛ ɔkwan biara so anaa nhwɛsode a wɔmpene so so.
| Customization level | Typical scope | Nhyɛsoɔ a ɛsua koraa a ɛhia |
|---|---|---|
| Branding a wɔde hyɛ nneɛma mu | Logo, labels, carton, tray mfonini ahorow, ne akwankyerɛ ahorow. | Adwini a wɔpene so, nkyerɛwde a wɔsan hwɛ mu, nsakrae a wɔhwɛ so, ne gua so kasa mu nhwehwɛmu. |
| Nsiesiei a Wɔde Yɛ Adwuma | Set composition, tray nhyehyɛe, akɛse, ne dodow. | Nneɛma a wɔde yɛ adwuma ho nkrataa a wɔapene so, nea ɛne ne ho hyia mu nhwehwɛmu, akontaabu a wɔagye atom, ne nneɛma a wɔde kyekyere nneɛma ho din. |
| Nneɛma a wɔyɛ mu nsakrae | Nsusuwii, nsa, ntamgyinafo, nneɛma, wie, anaa dwumadi. | Asiane nhwehwɛmu, mfonini a wɔpene so, nokwaredi, nokwaredi wɔ baabi a ɛho hia, ne nsakrae sohwɛ. |
| Nneɛma foforo a wɔyɛ | Adwene foforo anaa nnwinnade nhyehyɛe. | Nsusuwii a wɔde di dwuma wɔ ɔkwan a ɛfata so, sɛnea wɔde di dwuma ne asiane ho nhyehyɛe, mmara kwan so nhyehyɛe, nokwaredi, nea wogye tom, ne nhyehyɛe a wɔde kɔ baabi foforo. |
Nneɛma a wɔde kyekyere nneɛma, Set Completeness, ne Sterilization Compatibility
Nnwinnade ahorow no di nkogu wɔ adwumayɛ mu bere a nnwinnade ankorankoro bi nni hɔ, wɔakyerɛw so yiye, asɛe bere a wɔretu kwan, ɛne nea wɔde ahyɛ mu no nhyia, anaasɛ ɛyɛ den sɛ wobehu no. Hwehwɛ packing list a wɔahyɛ so ne akontaabu a etwa to a ɛne tray beae ne adwinnade a wɔde kyerɛ no hyia. Sɛ wopɛ nhyehyɛe ahorow a wotumi de di dwuma bio a, hwɛ sɛnea nsu a ɛkɔ mu, ɛwosow, sɛnea wɔpaapae mu, ɔkwan a wɔfa so siesie, emu duru, nneɛma a ano yɛ nnam a wɔbɔ ho ban, ne sɛnea ɛne ɔkwan a wɔpɛ sɛ wɔfa so yɛ sterilization no hyia.
Sɛ ade a ɛyɛ den a wotumi de di dwuma bio yɛ nhyehyɛe no fã a, hwɛ nea ɔyɛe no de no mu sterilization container options ka ho ne akwahosan adwumayɛbea no kwan a wɔagye atom a wɔfa so yɛ nneɛma foforo. Ɛnsɛ sɛ wosusuw sɛ ade anaa tray bi hyia esiane sɛ nnwinnade no hyɛ mu ankasa nti.
Hwɛ Tumi, Nneɛma a Wɔde Kɔma, Ɔsom, ne Ka Nyinaa Ho
Sɛ wodi mfiridwuma ne su pa ho ahwehwɛde ahorow ho dwuma wie a, fa toto aguadi nhyehyɛe no ho. Bisa tumi a ɛyɛ daa ne nea ɛsen biara, raw-material anohyeto ahorow, dodow a ɛba fam koraa a wɔkra, bere a wɔde di dwuma wɔ nhwɛsode mu, bere a wɔde di kan wɔ nneɛma a wɔyɛ, mmara a wɔde hyɛ nkɔm, Incoterms, nkrataa a wɔde kɔ amannɔne, ɔkwan a wɔfa so kyekyere nneɛma, ne amanneɛbɔ a wɔde bɔ amanneɛ a ɛkyɛ. Hwɛ nea ɔde nneɛma ma no de supply-chain and warehousing model , afei fa adanse te sɛ nnansa yi nsɛm a wɔde mae wɔ bere ano ho sɔ hwɛ.
Ka a wɔbɔ wɔ ne wurayɛ ho nyinaa ka nea ɛboro unit bo so koraa:
- ahwehwɛdeɛ, dinkyerɛw, akontabuo, sɔhwɛ, ne adansedie ho ka;
- nnwinnade, adwinni, nneɛma a wɔde kyekyere nneɛma, sterilization, nneɛma a wɔde fa, nnwuma, ne nneɛma a wɔakora so;
- nnwinnade a ayera anaasɛ asɛe, nneɛma a wɔde mena ntɛm a wɔde besi ananmu, ne nhyehyɛe a wɔsɛe no;
- sɛnea wosiesie, nneɛma a wɔde siesie, sɛnea wɔyɛ adwuma, wɔayi warranty afi mu, ne sɛnea wodi anwiinwii ho dwuma;
- ɛka ne asiane a ɛwɔ hɔ sɛ wɔbɛsesa wɔn a wɔde nneɛma ma no sɛ adwumayɛ no bɛyɛ nea wontumi nnye ntom a.
Ansa na wɔbɛpene so no, kyerɛw bere a wɔde bua mmuae, anwiinwii no wurayɛ, tumi krataa a wɔde bɛsan aba, nhwehwɛmu amanneɛbɔ, akwan a wɔfa so siesie anaa wɔbɛsesa, ne nkitahodi a ɛfa sɛnea wɔde nneɛma bɛkɔ soro no ho. XC Medico tintim ne mprempren akyi-tɔn ne warranty nhyehyɛe ma adetɔfo nhwehwɛmu.
Nhwɛso Oprehyɛn Adwinnade Manufacturer Scorecard
Fa nkyerɛwde biara hyɛ gyinapɛn biara mu fi 0 kosi 5, fa mu duru a wɔahyɛ ho nyansa no bɔ ho, na kyerɛw adanse a wɔasan ahwɛ mu no to hɔ. Fa apon a ɛyɛ ahyɛde a ɛfa pass/fail a wɔde ma mmara ne nhyehyɛe mu ahwehwɛde ahorow si hɔ sɛnea ɛbɛyɛ a aguadi mu nkontaahyɛde a ɛkorɔn rentumi ntua mmara sodi a ayera no so ka.
| Nhwehwɛmu beaeɛ Mu | duru a wɔahyɛ ho nyansa | Adanse | Twam pon |
|---|---|---|---|
| Mmara kwan so nipasu ne mmara kwan so gyinabea | 15% na ɛwɔ hɔ. | Adwumayɛ ho nsɛm, gua so tumi krataa, mfiri a wɔakyerɛw anaasɛ clearance sɛnea ɛfata. | Ɔhyɛ |
| Nhyehyɛe a wɔde hwɛ nneɛma pa so | 15% na ɛwɔ hɔ. | ISO 13485 scope/status, akontabuo aba, akwan a wɔfa so yɛ, kyerɛwtohɔ. | Ɔhyɛ |
| Mfiridwuma ne nneɛma a wɔyɛ ho tumi | 20% na ɛwɔ hɔ. | Nnwinnade, akwan horow, validation, adwumayɛfo, outsourced-process controls. | Ahyɛde ma scope |
| Nhwɛsode su ne adwumayɛ | 20% na ɛwɔ hɔ. | Nhwehwɛmu amanneɛbɔ, dwumadie sɔhwɛ, nhyiamu, reprocessing nhwehwɛmu. | Ɔhyɛ |
| Traceability ne nsakrae sohwɛ | 10% na ɛwɔ hɔ. | Lot trace exercise, nkrataa mu nsakrae, adetɔfo amanneɛbɔ apam. | Ɔhyɛ |
| Delivery ne supply a ɛkɔ so | 10% na ɛwɔ hɔ. | Tumi, bere a wɔde di dwuma, abakɔsɛm a wɔde ma, ahobammɔ stock, nhyehyɛe a ɛfa tebea a ebetumi asi ho. | Baabi a yɛntra |
| Ɔsom ne asetra mu mmoa | 5% . | Anwiinwii/CAPA nhyehyɛe, warranty, nsiesie, spare parts, escalation. | Baabi a yɛntra |
| Ɛka a wɔbɔ nyinaa ne aguadi ho nsɛm | 5% . | Landed ka, MOQ, akatua, tooling wurayɛ, warranty a wɔayi afi mu. | Baabi a yɛntra |
Fa nkontabuo krataa a woawie no sie wɔ adetɔnfoɔ fael no mu, kyerɛ nneyɛeɛ a wɔabue ne wuranom, na hyehyɛ ntamgyinafoɔ a wɔbɛsan asusu ho a egyina asiane ne adwumayɛ so. Hwɛ sintɔ ahorow a ɛba, anwiinwii, nteɛso nneyɛe, nneɛma a wɔde ma, mmuae a wɔde ma, ne nsakrae a wɔmma ho kwan bere a wɔapene so akyi.
Common Supplier Frɛmfrɛm Kɔkɔɔ
Hwehwɛ XC Medico Nneɛma a Wɔyɛ no mu
Saa nneɛma a ɛwɔ mu yi betumi aboa tumi nhwehwɛmu a wɔahyehyɛ. Ɛsɛ sɛ adetɔfo da so ara hwɛ sɛ nkrataa ne nneɛma a wɔyɛ no fata ma wɔn ankasa gua ne nea wɔpɛ sɛ wɔde bedi dwuma no.
Nsɛm a Wɔtaa Bisa
Dɛn ne adansedi krataa a ɛho hia sen biara ma obi a ɔyɛ mfiri a wɔde yɛ oprehyɛn?
Amansan adansedi krataa biako biara nni hɔ a ɛpene nea ɔyɛ ne ade biara so. ISO 13485 yɛ aduruyɛ-mfiri pa-nhyehyɛe gyinapɛn a ɛho hia, nanso ɛsɛ sɛ adetɔfo nso hwɛ sɛ nneɛma pɔtee bi ho mmara ahwehwɛde ahorow a ɛfa gua a wɔrekɔ no ho ne adansedi krataa no kɛse ne ne di mu.
So FDA dinkyerɛw kyerɛ sɛ FDA apene oprehyɛn adwinnade bi so?
Dabi, FDA adwumayɛbea a wɔkyerɛw wɔn din ne mfiri a wɔakyerɛw din no nkyerɛ sɛ wɔapene adwumayɛbea anaa mfiri no so, wɔaprapra mu, anaasɛ wɔama ho kwan. Hwɛ mfiri no nkyekyɛmu pɔtee ne FDA mmara kwan a ɛfata.
So ɛsɛ sɛ adetɔfo bi yɛ adwumayɛbea no mu akontaabu bere nyinaa?
Ɛnyɛ bere nyinaa na ɛte saa. Ɛsɛ sɛ akontaabu mu dɔ no gyina asiane so. Ebia nkrataa mu nhwehwɛmu, video a wɔyɛ no tee mu nhwehwɛmu, nhwɛsode ahorow, ne adanse a efi nnipa foforo hɔ bɛdɔɔso ama nneɛma bi a asiane nnim a wɔbɛtɔ. Asiane kɛse, nea enni mmoawa, nea wɔayɛ no sɛnea wɔpɛ, a ɛho hia, anaa bere tenten a wɔde bɛma ho nhyehyɛe betumi ama ɛfata sɛ wɔyɛ akontaabu wɔ beae hɔ.
Nhwɛsode dodow ahe na ɛsɛ sɛ wɔsɔ hwɛ?
Dodow no gyina asiane a ɛwɔ mfiri no mu, nsakrae, ɔkwan a wɔfa so sɔ hwɛ, ne nea wɔkra no kɛse so. Hwɛ units a ɛdɔɔso a ɛbɛma woasusuw nsusuwii ne dwumadie a ɛho hia ho, afei fa production lot a ɛdi kan no di dwuma bio hwɛ sɛ ɛtumi san yɛ bio.
So wobetumi ayɛ nnwinnade a wɔde yɛ oprehyɛn no sɛnea wɔpɛ ama ankorankoro din?
Yiw, nanso branding, set configuration, product nsakrae, ne product foforo a wɔyɛ hwehwɛ sɛ wɔyɛ nkrataa ne mmara kwan so nhyehyɛe ahorow. Kyerɛkyerɛ design wurayɛ, nokwaredi, labeling asɛyɛde, nsakrae sohwɛ, ne gua so tumi krataa ansa na woafi ase.
Mpɛn ahe na ɛsɛ sɛ wɔsan hwehwɛ adwumakuw bi a wɔapene so no mu?
Fa ntamgyinafo no si hɔ sɛnea asiane ne adwumayɛ ankasa te. Mfomso, anwiinwii, nneɛma a wɔde kɔma a entumi nyɛ adwuma yiye, nsakrae akɛse, adansedi krataa mu nsakrae, anaa nsɛm a ɛfa nteɛso ho no betumi ama wɔayɛ nhwehwɛmu anaa akontaabu a edi kan.
Awie
Nhwehwɛmu a etu mpɔn a wɔyɛ wɔ nneɛma a wɔyɛ no mu dan aguadi ho nsɛm ma ɛbɛyɛ adanse a ɛyɛ nokware. Kyerɛkyerɛ ahwehwɛde ahorow mu, hwɛ sɛ mmara ne nhyehyɛe ho nsɛm yɛ nokware, hwehwɛ pii ankasa, sɔ nhwɛsode ahorow hwɛ de gyina gyinapɛn ahorow a wɔapene so, na hwɛ nneɛma a wɔde di dwuma a ɛma daakye nneɛma a wɔbɛyɛ no yɛ pɛ. Nkonimdie krataa a wɔakyerɛw no ma ɛyɛ mmerɛ sɛ wɔbɛbɔ wɔn a wɔde nneɛma ma no gyinaesie ho ban na ɛma mfitiaseɛ a wɔde bɛhwɛ adwumayɛ so a ɛkɔ so.
Nsɛm a Wɔde Kyerɛw Nsɛm a Ɛwɔ Tumi
- Amanaman Ntam Ahyehyɛde a Ɛhwɛ Gyinapɛn So: ISO 13485—Aduruyɛ mfiri ahorow a wɔhwɛ so yiye ho nhyehyɛe.
- U.S. FDA: FDA dinkyerɛw ne mfiri a wɔpene so, nea wɔayi afi hɔ, anaa tumi krataa.
- U.S. FDA: Sɛnea wosua aduruyɛ mfiri bi ho ade na wɔtɔn.
- European Commission: Aduruyɛ mfiri ho mmara ne wɔn a wɔyɛ no asɛyɛde ahorow.
