Pro QC has over 40 years experience in quality control and quality assurance across virtually every industry.
Pro QC International is a provider of MDSAP (Medical Device Single Audit Program) audit services in China, delivering customized solutions to meet the unique requirements of the medical device industry.
Our focus is on aiding companies to navigate the complexities of MDSAP, verifying their supplier compliance, and improving the quality of their medical device production.
With offices in Shenzhen, Shanghai, and Ningbo, and a network of auditors across key manufacturing regions in China, Pro QC International offers MDSAP audits nationwide.
Our auditors and medical device consultants, knowledgeable in MDSAP protocols, have a profound understanding of conducting these specialized audits throughout China. They are experienced at identifying potential risks or areas that may impact the quality, safety, and regulatory compliance of medical devices. Our approach encompasses a thorough review of the entire product lifecycle, from design and development to post-market surveillance, under the MDSAP framework.
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With offices in strategic locations such as Shenzhen, Shanghai, and Ningbo, Pro QC International offers MDSAP audit services throughout China
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With over four decades of experience in quality auditing, Pro QC is a trusted partner for MDSAP audits. Pro QC customizes solutions to each client’s specific needs, deploying auditors to act as their representatives on the ground, identifying non-compliance or issues that could affect their business objectives and regulatory adherence.
The MDSAP audits provided by Pro QC in China cover critical aspects like device marketing authorization, design and manufacturing processes, and adherence to the specific regulatory requirements of participating MDSAP countries. Our services extend beyond audits, as we offer guidance and support in MDSAP implementation, ensuring a smooth journey towards compliance and successful audit outcomes.
Clients can rely on our comprehensive support from the initial audit planning to the implementation of corrective actions and ongoing compliance management.
Pro QC’s MDSAP auditors are selected through a rigorous recruitment process, based on their experience, competencies, and specific certifications related to the medical device industry. This ensures that our MDSAP audits are delivered by highly specialized professionals.
In China, our auditors bring their knowledge of the local manufacturing environment, regulatory landscapes, and international medical device standards. They are trained to conduct ISO 13485 and MDSAP audits, ensuring that medical device manufacturers meet the rigorous requirements of the participating regulatory authorities.
Pro QC International leverages over four decades of experience in quality auditing to deliver customized solutions tailored to each client’s specific needs
As a consulting company specializing in medical device audits, the range of solutions we provide to our clients in China extends beyond MDSAP and includes the following audits:
Find out more about our related services by clicking below:
ISO 13485 Audit Services
Read more
How to combine an MDR 2017/745 and an ISO 13485 Supplier Audit
Factory and Supplier Audit in China
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In which country are you based?AfghanistanAlbaniaAlgeriaAndorraAngolaAntigua and BarbudaArgentinaArmeniaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBhutanBoliviaBosnia and HerzegovinaBotswanaBrazilBruneiBulgariaBurkina FasoBurundiCôte d'IvoireCabo VerdeCambodiaCameroonCanadaCentral African RepublicChadChileChinaColombiaComorosCongo (Congo-Brazzaville)Costa RicaCroatiaCubaCyprusCzechia (Czech Republic)Democratic Republic of the CongoDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatiniEthiopiaFijiFinlandFranceGabonGambiaGeorgiaGermanyGhanaGreeceGrenadaGuatemalaGuineaGuinea-BissauGuyanaHaitiHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsraelItalyJamaicaJapanJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMauritaniaMauritiusMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew ZealandNicaraguaNigerNigeriaNorth KoreaNorth MacedoniaNorwayOmanPakistanPalauPalestine StatePanamaPapua New GuineaParaguayPeruPhilippinesPolandPortugalQatarRomaniaRussiaRwandaSaint Kitts and NevisSaint LuciaSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited States of AmericaUruguayUzbekistanVanuatuVenezuelaVietnamYemenZambiaZimbabwe
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Pro QC has been providing quality assurance, engineering and consulting services since 1984.
We offer quality solutions in over 88 countries and we are continuously expanding our network.
We offer online reporting and detailed reports within 24 hours of job completion.
Our global engineering team has the requisite industry expertise to verify quality and conformance.
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