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Capamed :: Med Dev Consulting

Medical Device Consulting - Regulatory Affairs. Quality Systems. Product Approval.

http://www.capapharm.com/

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CONTACTS AT CAPAPHARM.COM

Lu Anne Johnson

PO ●●● 63

Ha●●en , WI, 54841

US

1.71●●●●2490
1a●●●@capamed.com

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Lu Anne Johnson

PO ●●● 63

Ha●●en , WI, 54841

US

1.71●●●●2490
1a●●●@capamed.com

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Capamed :: Med Dev Consulting | capapharm.com Reviews
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Medical Device Consulting - Regulatory Affairs. Quality Systems. Product Approval.
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Capamed :: Med Dev Consulting | capapharm.com Reviews

https://capapharm.com

Medical Device Consulting - Regulatory Affairs. Quality Systems. Product Approval.

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1

Capamed :: EU Representative

http://www.capapharm.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.

2

Capamed :: Management

http://www.capapharm.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.

3

Capamed :: Audits

http://www.capapharm.com/about-us/audits

Products. Processes. Organizations. QM Systems. Capamed audits quality systems according to ISO 13485, ISO 9001, and FDA QSR (21 CFR 820). We will provide you with an overview of the audited area’s compliance as well as specific instructions on how to resolve any differences. We conduct our audits in accordance with the requirements of the FDA or appropriate European authority. All audits are conducted by a certified auditors. Detection of vulnerabilities and deviations. Outsourcing of Internal Audits:.

4

Capamed :: Technical Documentation

http://www.capapharm.com/europe/technical-documentation

Conformity Assessment. CE Mark. For CE marking of a medical device the Medical Device Directive requires that technical documentation is created and maintained. The technical documentation is required for all classes of medical devices. The content is defined in the Medical Device Directive (Annex 2 and Annex 7). Review of existing documents. Compilation of the technical documentation. Evidence of compliance with the "Essential Requirements". Implementation and documentation of risk management (ISO 14971).

5

Capamed :: Notified Body

http://www.capapharm.com/europe/notified-body

Selection. Preparation. Audit Support. If a medical device manufacturer wants to bring a medical device to the European market, but does not have a registered place of business in the EU, the Medical Device Directive requires that a European Authorized Representative located in the EU be appointed, who will represent the manufacturer with the national Competent Authorities. Registration of your device with the national Competent Authorities. A point of contact for all national Competent Authorities.

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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.

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