Medical Devices & IVDs - Case studies
Medical Device Marketing Approval
QUICK FACTSCLIENT Large Medical Device Manufacturer SERVICE SUPPLIED
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OBJECTIVE
Assist the client in bringing three new medical devices to market within the United States, via the 510(k) process and obtaining a CE marking within the EU SOLUTION DETAILS The client was looking to obtain marketing clearance/approval in the US and EU for their line of tubing products RJR assisted in a complete review of all 510(k) submissions prior to filing them for FDA review. Based on our internal review, comments on current recognized standards, and FDA guidance documents, each 510(k) was revised prior to filing with the FDA. RJR also reviewed the technical files for each of the three products and verified that each product complied with the essential requirements of the Medical Device Directive. Each technical file was revised to add additional content prior to review by the Notified Body for approval of conformity. OUTCOME All submissions were approved by the FDA and European Notified Body. Each product was granted a 510(k) clearance and CE mark, so that they can be lawfully marketed in both the US and the EU. |
Medical Device GMP Compliance/ISO Certification
QUICK FACTSCLIENT Large Medical Device Manufacturer SERVICE SUPPLIED
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OBJECTIVE
Assist a large medical device company in obtaining CFR part 820 compliance and ISO certification for their new manufacturing facilities located in both the United States and Europe. SOLUTION DETAILS The client was starting up new manufacturing operation in the United States and the EU and needed to establish GMP compliance with the appropriate regulations in each region. RJR worked with the client to locate a preferred Notified Body in the EU to provide ISO 13485 Certification. RJR then worked with the client to develop a quality manual, that encompassed their operations, including but not limited to product release, labeling, device specifications, CAPA, post-marketing surveillance, customer complaints, product recall, and management review procedures. RJR also helps the client revise or generate the appropriate SOP's and/or quality records. RJR also conducted three separate mock audits to determine where GMP gaps still existed in each facility. In each instance, RJR acted as the appropriate healthcare authority, when auditing the facility. RJR also worked with the client in providing effective solutions to any post audit non-conformances found, so they could be corrected prior to inspection from the Notified Body. OUTCOME ISO Certification was achieved in less than 6 months from the start of the project. Facilities continue to pass subsequent inspections with no major violations reported. |
Regulatory Analysis/Support for Dental Devices in Latin America
QUick FactsCLIENT Marketer of Dental Aligner Systems SERVICES SUPPLIED
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OBJECTIVE
Due to the evolving requirements for Medical Devices in many Latin American countries, the Client wanted to obtain a clearer picture of their current product licenses in Latin American markets, which licenses required renewals, when those renewals needed to be filed and what documents are required for the renewals. The Client also wanted to understand the registration requirements for a number of other countries where they were considering market entry. In addition, the Client was also interested in suggestions to improve the time for shipments from the US to the end user. SOLUTION DETAILS RJR assisted with the following tasks to help the Client reach their objectives in Latin America:
OUTCOME The Client obtained the information necessary to ensure timely renewal of their licenses in various Latin American Markets. They leveraged the regulatory intelligence information make internal decision regarding future growth markets for their business. Regarding the shipping process, RJR was able to identify multiple areas that could be improves to reduce shipping time down to Latin American customers. |
EU MDR Gap Analysis
QUick FactsCLIENT Marketer of Nocturnal Enuresis devices SERVICES SUPPLIED
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OBJECTIVE
Due to the evolving requirements for Medical Devices i many Latin American countries, the Client wanted to obtain a clearer picture of their current product licenses in Latin American markets, which licenses required renewals, when those renewals needed to be filed and what documents are required for the renewals. The Client also wanted to understand the registration requirements for a number of other countries where they were considering market entry. In addition, the Client was also interested in suggestions to improve the time for shipments from the US to the end user. SOLUTION DETAILS RJR assisted with the following tasks to help the Client reach their objectives in Latin America:
OUTCOME The Client obtained the information necessary to ensure timely renewal of their licenses in various Latin American Markets. They leveraged the regulatory intelligence information make internal decision regarding future growth markets for their business. Regarding the shipping process, RJR was able to identify multiple areas that could be improves to reduce shipping time down to Latin American customers. |