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Capamed :: Med Dev ConsultingMedical Device Consulting - Regulatory Affairs. Quality Systems. Product Approval.
http://www.capamed.com/
Medical Device Consulting - Regulatory Affairs. Quality Systems. Product Approval.
http://www.capamed.com/
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Capamed :: Med Dev Consulting | capamed.com Reviews
https://capamed.com
Medical Device Consulting - Regulatory Affairs. Quality Systems. Product Approval.
capamed.com
Capamed :: Process Validation
http://www.capamed.com/medical-devices/process-validation
Missing or insufficient validation of manufacturing processes is one of the most common reasons for warning letters from FDA inspections. Also as part of the ISO 13485 certification process, validation is playing an increasingly important role. The FDA's definition of Process Validation:. Management of validation projects. Definition and documentation of process requirements and process parameters. Creation of a validation plan. Implementation and documentation of risk analysis. Europe - CE Marking.
Capamed :: Management
http://www.capamed.com/about-us/management
Experienced consultants. Dedicated to your success. Capamed Inc was founded by Lu Anne Johnson after many years of clinical and corporate experience in the medical field. In addition to leading the Capamed team, Ms. Johnson also provides consulting services to company clients. 25 years of management experience in the medical field. FDA approvals and inspections since 1990. Member of the ASRT and ART. Experienced QA expert and auditor. Europe - CE Marking.
Capamed :: FDA Approval
http://www.capamed.com/fda/510k
510k PMA. IDE. Product approval of medical devices by the FDA is dependent on the FDA’s classification and product code for the device. A 510k application (premarket notification) is sufficient for class ll products. For class III (and some unclassified) products a PMA application (premarket approval) is required. In both processes, the manufacturer must demonstrate:. The products were developed and manufactured in compliance with GMP regulations (21 CFR 820). Building an FDA compliant quality system.
Capamed :: Risk Management
http://www.capamed.com/medical-devices/risk-management
ISO 14971. Product Development. Process Validation. Post Market Surveillance. The market clearance procedures of the U.S. FDA and the EU (European Union) require the implementation of a suitable risk management process. Therefore, risk management is an integral part of product and process development, leading to more stable and safe products, but also increased efficiency by focusing on the essentials. All established methods of risk management, in particular to ISO 14971, include three common steps:.
Capamed :: EU Representative
http://www.capamed.com/europe/eu-representative
Registration. Representation. Communication. If a medical device manufacturer does not have a registered place of business in the EU, but wants to bring medical devices to the European market, the Medical Device Directives requires that a European Authorized Representative located in the EU is appointed, who represents the manufacturer with the national Competent Authorities. Registration of your device with the national Competent Authorities. Contact point for all national Competent Authorities.
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Software Validation :: Impressum
http://www.softwarevalidation.de/impressum1
47533 Kleve, Germany. Geschäftsführer: Dr. Bernhard Bauer. Umsatzsteuer-ID: DE 814 782 190. Handelsregister: Amtsgericht Kleve HRB 8435. Die Übermittlung von personenbezogenen Daten (Name, Anschrift usw.) erfolgt auf freiwilliger Basis. Wir weisen darauf hin, dass die Übermittlung dieser Daten über das Internet Sicherheitslücken aufweisen kann. Diese Daten werden von uns nur für die von Ihnen mitgeteilten Zwecke erhoben und nicht an Dritte weitergegeben.
Software Validation - Applicable IT Systems
http://www.softwarevalidation.de/en/software
Which software must be validated? Any software application that could influence the results of quality-related activities and processes must be validated. Quality-related activities and processes are defined in the applicable regulations. Examples of quality-related processes and supporting software applications:. Production (e.g. control and recording of critical process parameters). Product development (e.g. databases in clinical trials). Quality control (e.g. automated test equipment).
Capamed :: Qualitätsmanagement
http://www.capamed.de/medizinprodukte/qualitaetsmanagement
ISO 13485. FDA QSR. 21 CFR 820. In den USA und Europa werden ähnliche Anforderungen an die Qualitätssysteme zur Entwicklung, Herstellung und Vertrieb von Medizinprodukten gestellt. Trotzdem gibt es Unterschiede in der Auslegung und der Inspektionstiefe. Aufbau und Unterhalt eines Qualitätssystems. Analyse bestehender Prozesse und Dokumente. Ablaufplan für erforderliche Prozeduren. Unterstützung bei der Implementierung dieser Prozeduren. Europa - CE Kennzeichnung.
Capamed :: Medizinprodukte
http://www.capamed.de/medizinprodukte
Alle Klassen. Aktive. Software. IVD. Medizinprodukte unterliegen der behördlichen Überwachung: in Deutschland durch das Medizinproduktegesetz, in Europa durch die EG Richtlinien 90/385/EEC (AIMD), 93/42/EG (MDD) und 98/79/EG (IVD), in den USA durch die Regularien der Food and Drug Administration FDA. Capamed berät und unterstützt Ihr Unternehmen bei diesen Projekten:. Aufbau und Optimierung eines Qualitätsmanagementsystems bis zur Zertifizierung. Risikomanagement nach ISO 14971. Europa - CE Kennzeichnung.
Software Validation - Approach
http://www.softwarevalidation.de/en/approach
How do we validate software? Software validation provides documented evidence that your software meets applicable requirements. From the user’s perspective (User Requirements Specifications or "URS"), validation determines whether the software supports quality-related processes. We provide a structured approach and SOPs to determine which software systems, or parts thereof, must be validated. The requirements and validation relevant functions of software systems are documented in the URS.
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Capamed :: Med Dev Consulting
Regulatory Affairs and Quality Management. With our offices in the U.S. and Germany, we support you with expertise and years of experience in meeting the regulatory requirements for quality management, product development, risk management, validation, GMP, documentation and approval. ISO 13485 and 9001. SOPs and Quality Manual. Europe - CE Marking.
Capamed :: Med Dev Consulting
Regulatory Affairs und Qualitätsmanagement. Capamed hat sich auf die Beratung von Herstellern medizinischer Produkte spezialisiert. Mit unseren Standorten in Deutschland und den USA unterstützen wir Sie mit Kompetenz und langjähriger Erfahrung bei der Erfüllung der regulatorischen Anforderungen. Validierung (Produkt, Prozess, Software). EU Zulassung, CE Kennzeichnung. Zertifizierungsaudits der Benannten Stelle. FDA Zulassungen, 510k, PMA. FDA und EU Vertreter. FDA QSR, 21 CFR 820.
ÇAPA MEDİKAL - SAĞLIK LOJİSTİK ŞİRKETİ
35 yılı aşan geçmişimizde Önce İnsan ve İstikrarlı Fiyat ilkelerinden ödün vermeden başta özel hastaneler olmak üzere kamu ve üniversite hastanelerinin, eczanelerin ve ilgili dağıtım firmalarının medikal sarf malzemesi ihtiyacını büyük bir titizlik ve hız ile karşılıyoruz. Sağlık sektörünün spesifik medikal sarf malzemesi talebini karşılıyor; bu ürünleri yalnızca taşıyan değil, tanıyan uzman ekiplerimizle Türkiye sağlık sektörünün değer yaratan paydaşları arasındaki yerimizi alıyoruz. AĞIZ BAKIM SETİ (2).
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35 yılı aşan geçmişimizde Önce İnsan ve İstikrarlı Fiyat ilkelerinden ödün vermeden başta özel hastaneler olmak üzere kamu ve üniversite hastanelerinin, eczanelerin ve ilgili dağıtım firmalarının medikal sarf malzemesi ihtiyacını büyük bir titizlik ve hız ile karşılıyoruz. Sağlık sektörünün spesifik medikal sarf malzemesi talebini karşılıyor; bu ürünleri yalnızca taşıyan değil, tanıyan uzman ekiplerimizle Türkiye sağlık sektörünün değer yaratan paydaşları arasındaki yerimizi alıyoruz. AĞIZ BAKIM SETİ (2).
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