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Helping to Shape a Healthier World For 72 years delivering health and well being has been our top priority Our expertise in high quality plastic molding for the healthcare industry has made us a trusted partner for developing and manufacturing medical devices specialty rigid packaging and liquid dosing and dispensing systems
Asia Connection Co Ltd is an US supplier of medical and home healthcare products located in Asia since 1993 blood pressure monitor dispensing pins vented vial access devices elastomeric infusion pu more Jawon Medical Co Ltd Address Singsang Li Jinryang 53 856 0993 FDA Registration Quality ISO 13485
1 Certified to ISO 13485 CE registered to FDA with quality management fully documented 2 Have a dedicated personnel to ensure conformity to requirements related to medical devices 3 Very large manufacturing center with 11 workshops in the same place
Gain Market Access Whether you are a manufacturer at any stage of the medical device lifecycle or a supplier ISO 13485 gives you international recognition for quality management systems The framework and principles of ISO 13485 sits at the core of additional regulatory requirements like Medical
Transforming the Pharmacy Care Delivery Model The Pharmacy Management edition of HealthTech Magazine features a cover story on the Autonomous Pharmacy and how Omnicell s portfolio is transforming medication management Read Now Our portfolio crosses the entire continuum of care from hospital to home Central Pharmacy Dispensing
Jul 07 2020 Certvalue is one of the best ISO 13485 Consultant in Thailand for providing ISO 13485 Certification Thailand Bangkok Chiang Mai Pattaya City Mueang Chang Rai Surat Thani and other major cities in Thailand with the services of implementation training documentation gap analysis registration Audit and templates services at affordable cost to all organizations to get certified under
Affinity Life Sciences is a cGMP and ISO 13485 compliant company can provide custom services including in vitro diagnostic kit production reagent formulation vial/bulk reagent filling and labeling kit assembly and labeling and microplate coating of proteins nucleic acids cells or other target molecules
As the global COVID 19 pandemic continues to challenge the delivery of healthcare worldwide ICU Medical is committed to working with our customers to ensure you have the IV solutions systems and consumables you need to provide essential care Because evolving protocols and variations in care shouldn t mean fluctuations in supply ICU Medical
Dec 07 2020 Top Clean Injection is ISO 13485 certified This company is also a medical device manufacturer Top Clean Injection supports customers from the conception of the medical device to its sterilization in the packaging Additional services Product design tool making workshop Sterilization of medical devices by the STERRAD process
KILITCH DRUGS INDIA LTD is a pharmaceutical company with more than 30 years of experience in manufacturing of formulations in solid liquid and parenteral forms Our world class manufacturing facility for parenterals is located in Mumbai India with a dedicated Cephalosporins dry powder section General Injectables SVP ampoules/vials and Ophthalmic Nasal drops
ISO 13485 is similar in scope and intent to ISO 9001 but it includes additional requirements specific to medical devices while excluding certain ISO 9001 provisions Therefore in most jurisdictions ISO 9001 certification is not an acceptable substitute for certification to the requirements of ISO 13485
Mar 17 2021 The Medical Devices Branch of Singapore s Health Sciences Authority HSA has announced in a webinar held on March 2 that it intends to only issue dealer licenses to companies that can provide either 1 a Medical Device Single Audit Program MDSAP certificate or 2 an ISO 13485 certificate from a third party certification body CB accredited by the Singapore Accreditation Council
Gain Market Access Whether you are a manufacturer at any stage of the medical device lifecycle or a supplier ISO 13485 gives you international recognition for quality management systems The framework and principles of ISO 13485 sits at the core of additional regulatory requirements like Medical Devices Single Audit Program MDSAP
Dec 31 2019 All of our facilities are ISO 13485 certified and cGMP compliant Select sites are registered with the FDA to perform drug re packaging and label reconciliation ready for distribution West has an embedded Lean Six Sigma culture to drive out waste and optimize efficiencies
BSI has developed a range of resources to support your organization and provide you with all the information you need wherever you are on your BS ISO 39001 journey BS ISO 39001 Client manual A top level guide to help you understand BS ISO 39001 and the benefits it can bring your organization
Found in 2009 Wuxi NEST Biotechnology is a worldwide manufacturer of plastic laboratory products Decades of plastic injection molding experience allows us to maintain the highest quality and performance standards expected by the hospitals research institutions and indusrial/clinical laboraories that we serve NEST is your best choice for laboratory consumables
Validating product performance through enhanced quality systems ISO 13485 Microbix has therefore developed a line of clinically important QAPs an opportunity well suited to its capabilities and market bona fides and a large low risk market opportunity
Mar 05 2021 FDA Provides Guidance on Switches to Container Closure The U S Food and Drug Administration FDA provided guidance that addresses changes to the supply chain due to COVID 19 including its regulatory process for manufacturing and controls CMS and chemistry Materials like glass vials stoppers test swabs and reagents have been affected
Virtual Instructor Led Training ISO 13485 2016 Medical Devices Internal Auditor SAI Global Assurance Learning is an Exemplar Global certified TPECS provider This course meets the knowledge examination requirements of the Medical Devices Quality Management Systems MD certification scheme
ISO 13485 medical devices A silanized glass screw cap vial with Top Hat closure Appropriate closures are also provided for direct syringe needle access to the prepared solution The theoretical and actual weight of the drug is listed with dilution instructions In the case of
Jan 02 2019 NeoMed a leading innovator of ENFit products and accessories has expanded its supply efforts by opening a new distribution center in Costa Mesa CA The location officially opened on December 12 2017 to help serve the supply needs of NeoMed s growing customer base NeoMed President Ingram expressed enthusiasm about the launch of the new
Global market access for medical device manufacturers With more than 70 000 certified locations and clients in over 180 countries we work with international regulators to enable medical device manufacturers all over the world get their products to market quickly while complying with the latest regulatory requirements
Oct 28 2021 Standards for QMS ISO 13485 risk management ISO 14971 clinical trials ISO 14155 and biocompatibility ISO 10993 are recommended depending on the type of medical device In Malaysia the Medical Device Authority under the Ministry of Health is the key regulatory body responsible for the regulation of medical devices in the Malaysian market
Become ISO 13485 certified under accreditation with AFNOR Group a leading certification body for more than 20 years ISO 13485 regulatory system certification is recognized by all professionals in the medical device industry from design to dismantling including distribution and maintenance
Dec 15 2020 Our global product portfolio enables clinicians to be more efficient and effective in treating patients at the hospital bedside in the operating theater in critical care units at home and in the dialysis clinic We are working alongside our partners to find new and smarter ways to improve patient outcomes prevent complications before they become life threatening and increase access to care
Aug 27 2018 If you are located in France for example you should look for a certified body in France accredited for both CE marking and ISO 13485 Same for other countries This is the most simple case Canada If you are selling in any other country and also Canada select a Certified Body accredited for ISO 13485 CE marking and MDSAP
Nova s global manufacturing operations take place in four facilities certified by the International Organization for Standardization ISO and are located in Waltham and Billerica Massachusetts USA and Taipei Taiwan These facilities occupy a total of 420 000 square feet 42 000 square meters of manufacturing space
Access Bio s mission is to improve the lives and well being of people around the world Through the development of in vitro diagnostics technology Access Bio has successfully commercialized the highest quality products to battle malaria and other serious diseases We are a trusted partner to international public health agencies and organizations including the World Health Organization
Mar 16 2021 The ISO 13485 certification confirms our strategic focus and our mindset of quality in digital engineering Software as a medical device is a digital transformation enabler for key players in
May 02 2017 To explain further ISO 13485 2016 excludes some of the requirements of ISO 9001 2015 that are not appropriate as regulatory requirements Because of these exclusions organizations whose quality management systems conform to ISO 13485 cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001
The SARS CoV 2 Rapid Antigen Test is intended to detect specific antigen from the SARS CoV 2 virus in individuals suspected of COVID 19 The test is intended for professional use only See how it works Roche is deeply committed to supporting the global response to put an end to the COVID 19 pandemic The SARS CoV 2 Rapid Antibody Test can be
ISO 13485 2016 medical devices quality management systems specifies the requirements for organizations in any aspect of a medical device lifecycle including both product and related services By implementing a structured framework that aligns with the strategic direction of the business organisations can experience Increase patient safety and
Increase access to more markets worldwide with ISO 13485 certification Outline how to review and improve processes across your organisation Increase efficiency reduce costs and monitor supply chain performance Demonstrate that you produce safer and more effective medical devices Meet regulatory requirements and customer expectations
EN ISO 13485 2012 that is identical to ISO 13485 2003 with the revision of the European Foreword and Annexes ZA ZB and ZC Incorporated into the Medical Device Single Audit Program MDSAP ISO 13485 kaikkialla 17 Recognized standard by Health Canada Note Any ISO 13485 certificate is not enough for Health Canada
thermoplastic elastomers TPEs used in the medical and pharmaceutical sectors These include PE PP ABS SAN PC/ABS PC PA6 66 and 12 cyclic olefins COP high performance polymers and elastomers such as EVA SEBS TPU and PEBA Clariant tRUstEd MatERials glOBal isO 13485 Production sites
Fresenius Medical Care is the world s leading provider of products and services for individuals with renal diseases of which around 3 7 million patients worldwide regularly undergo dialysis treatment Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers
