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Internal Auditing

Internal audit resourcing is a strain for many companies.

Whether you need a mock audit to test your new or revised quality management system under the multitude of compliance hurdles such as MDSAP and MDR/IVDR or lack seasoned auditors to provide value-added internal audits, AlvaMed can provide dedicated resources you can trust.  In addition to identifying the issues a regulator is likely to find, we help you develop a strategy for correcting them.

Assess the scope of the QMS and plan for an approach that satisfies both the speed and strategy to market.

Define the methods, materials, and resources needed to accomplish the audits/inspections in manageable areas.

Conduct the audits/inspections through a relaxed collaborative effort, giving employees the feeling of ownership and accomplishment.

Provide management with a detailed summary of the audit/inspection and all results.

If requested, provide assistance in how to approach logical solutions to issues or how to utilize best practices.

AlvaMed’s team of experienced auditors can provide the assistance and guidance toward compliance.

My team was faced with the need to establish medical device QMS procedures for our combination product in a short timeframe to meet product development needs and corporate milestones. The AlvaMed team developed custom SOPs aligned with our specific operational needs while maintaining compliance with international standards and regulations in the regions where we plan to market our product. The team kept me in the loop with weekly meetings where I was able to recommend adjustments to align better with our group’s needs, and the QMS documents were released within a timeframe that met my organizations’ required schedule. AlvaMed’s expertise has provided us with a strong foundation for our ongoing operations. 

Director of Device Quality

International MedTech Company

We were working on a very tight deadline to submit 483 responses to the FDA with extremely limited resources to get the job done. We hired AlvaMed to help us, and they were able to on-board, advise us on strategy, work with our team, and draft responses to our findings in less than 2 weeks. Before bringing the AlvaMed team on, we worried this would not be an achievable task. We were thrilled with the outcomes and our team gained an incredible amount of knowledge in working with AlvaMed’s experts. I would highly recommend AlvaMed to any company requiring QA/RA support.

Directory of Quality

International Med-Tech Company

We were in search of a consulting firm to assist us in tailoring our existing quality management system to meet our specific requirements. That’s when we engaged AlvaMed, and I must say, their performance was truly outstanding.

AlvaMed swiftly grasped the intricacies of our unique needs and hurdles, crafting a bespoke solution that perfectly aligned with our objectives. Their adeptness in implementing the new system, conducting internal audits, and delivering design assurance support was not only impressive but also executed seamlessly, adhering to both our schedule and budget constraints.

I recommend AlvaMed to any medical device company in search of a consulting partner. Their competence and commitment are second to none, and they have undoubtedly been instrumental in our success.

Kelly Ashfield

Materna

AlvaMed’s dedication to quality and compliance is truly commendable. Their prompt and transparent actions in addressing the DHF audit findings showcase their commitment to excellence. What stands out to me is their meticulous gap assessment and proactive approach to risk management, which clearly illustrates their commitment to continuous improvement. I’m confident in their ability to maintain these high standards and look forward to continued collaboration.

Angel Iglesias

Anika

I’d like to take a moment to express my gratitude for AlvaMed’s quick response, experience and professional approach to addressing our efforts to respond to an audit finding. AlvaMed conducted a comprehensive assessment of our product technical documentation, identified gaps related to current standards and regulations, and provided a clear definition of objectives and a plan to address the gaps.

I am thoroughly satisfied with the level of expertise and diligence displayed by AlvaMed throughout this process. Without hesitation, I would highly recommend them to any medical device company seeking a consulting company to address compliance concerns.

Erik McWilliams

Anika

We are extremely satisfied with the quality support services provided by AlvaMed. Their expertise in the medical device industry, tailored solutions, and transparent communication have been invaluable to our operations at Goddard Technologies, Inc. We highly recommend their services to anyone seeking top-notch quality support.

Charlie

Goddard Technologies, Inc.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

Ready To Schedule A Call?

We look forward to discussing AlvaMed’s services with you.

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Internal Auditing FAQ's

Compliance is not only a job for quality departments.  Top management has a responsibility to provide resources (including time, money, people) to manage an effective quality management system.

AlvaMed has access to people who possess the skills and knowledge to be able to accomplish these tasks.

AlvaMed’s team can assist in the understanding of how to address the issues both before they happen or as a remediation.

Mark Cox

President and Founder

Schedule time with Mark to discuss how AlvaMed can prepare your company for internal audits. 

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