510(k) Submissions

AlvaMed offers consulting services to help medical device companies prepare and submit successful 510(k) applications to the FDA.

MDR Compliance

A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.

Clinical Evaluation

Read this case study to discover how AlvaMed helped a client navigate the complex EU MDR and provided expert clinical evaluation support.

EXCEL SPREADSHEET REQUIREMENTS AND VALIDATION PROCESS

Under 21 CFR 11.10 Controls for closed systems, all spreadsheets that are used to facilitate the product and/or quality system decision-making processes need to be within compliance, including requirements for validation, accurate copies and protection of records, limited system access to authorized individuals, audit trails, authority, operational and device checks, training, electronic signatures, and change […]

Training

AlvaMed’s approach to training sets us apart from competitors. Our training is customized to the client’s needs and delivered by regulatory, quality and clinical consultants. 

Class III FIH Trial Case Study

AlvaMed was able to support the company’s aggressive timelines to gain study approval and operationally prepare the company to open enrollment in advance of product availability.

IDE Case Study

AlvaMed effectively conducted the IDE study, performed study data cleaning, closure, issued the final study report after meeting the client’s enrollment needs, and received De Novo clearance for the client’s device based on final IDE study report data.

510(k) Clearance

The labeling update was accepted and the device was cleared. The submission was difficult due to the FDA’s test data expectations and the limited time remaining in the review window. The labeling update suggested by the team at AlvaMed successfully brought the client through the review process to market clearance.

Regulatory Strategy

Client feedback rated AlvaMed’s work excellent and the results enabled the client to: Have the justification to go to the parent company’s management and request additional funding to accelerate two highly attractive technologies, maintain development funding for two other technologies, shelve the remaining technology.

Large Company QMS Harmonization

AlvaMed’s work product was highly regarded by the company’s global quality systems and regulatory leadership. The global standards remain in effect today and the company has provided the best indication of satisfaction by having AlvaMed continue to support the effort, developing lower level procedures to align with the policy standards.