ISO 13485:2016

WHAT IS ISO 13485:2016

ISO 13485:2016 specifies requirements for a high-quality control machine wherein a business enterprise wishes to illustrate its capability to offer medical gadgets and related services that constantly meet customer and applicable regulatory necessities. Such agencies can be worried in a single or more degree of the lifestyles-cycle, which includes design and improvement, production, garage, and distribution, set up, or servicing of a clinical tool and design and improvement or provision of associated activities.

IMPORTANCE OF ISO 13485:2016

If relevant regulatory necessities permit exclusions of design and development controls, this can be used as a justification for his or her exclusion from the great control system. These regulatory necessities can provide opportunity techniques that are to be addressed in the high-quality management device. It is the obligation of the organization to make sure that says of conformity to ISO 13485:2016 reflect any exclusion of layout and development controls.

ISO 13485:2016 Certification by Country

AfghanistanAlbaniaAlgeriaAndorra
AngolaArgentinaArmeniaAustralia
AustriaAzerbaijanBahamasBahrain
BangladeshBarbadosBelarusBelgium
BelizeBeninBhutanBolivia
Bosnia and HerzegovinaBotswanaBruneiBulgaria
Burkina FasoBurundiCabo VerdeCambodia
CanadaChadChileChina
ColombiaComorosCosta RicaCroatia
CubaCyprusCzech RepublicDenmark
DjiboutiDominicaDominican RepublicEcuador
EgyptEl SalvadorEquatorial GuineaEritrea
EstoniaEthiopiaFijiFinland
FranceGabonGermanyGreece
GrenadaGuatemalaGuineaGuyana
HaitiHondurasHungaryIceland
IndiaIndonesiaIranIraq
IrelandIsraelItalyJamaica
JapanJordanKazakhstanKenya
KiribatiKuwaitLaosLatvia
LebanonLiberiaLibyaLiechtenstein
LithuaniaLuxembourgMacedoniaMadagascar
MalawiMalaysiaMaldivesMexico
MicronesiaMoldovaMonacoMongolia
MoroccoMyanmar NamibiaNauru
NepalNetherlandsNew ZealandNicaragua
NigerNigeriaNorth KoreaNorway
OmanPanamaPeruPhilippines
PolandPortugalQatarRomania
RussiaRwandaSaint LuciaSamoa
San MarinoSaudi ArabiaSenegalSerbia
SingaporeSlovakiaSolomon IslandsSouth Africa
South KoreaSpainSri Lankastate_name
SwedenSwitzerlandTaiwanTajikistan
ThailandUnited Arab Emirates UAEUnited Kingdom UKUruguay
UzbekistanVanuatuVenezuelaVietnam
YemenZambiaZimbabwe