A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.
Performing all the activities required to administer and maintain your QMS can be a strain on resources, especially for small companies. If you need help figuring out the best way to respond to a CAPA, prepare for a management review, or simply lack bandwidth to push through change orders in document control, AlvaMed can help. Our team has the experience and flexibility to step in and help keep your QMS running smoothly.
We work with client stakeholders to determine those areas of the QMS that may benefit from external support.
We will match the level of support to your needs, identifying the right resources to ensure your objectives can be met.
We can work with you or autonomously to manage those aspects of the QMS where assistance is needed in either short- or long-term assignments.
A small medical device company facing limited resources successfully updated their QMS and achieved MDR compliance with AlvaMed’s expert guidance and efficient tools.
CASE STUDY
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.
Materna
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.
Goddard Technologies, Inc.
We are delighted to express our appreciation for the exceptional quality engineer support provided by AlvaMed. With AlvaMed’s guidance, we’ve not only met regulatory requirements but have also exceeded our own quality benchmarks. AlvaMed has proven to be a valuable partner in our pursuit of excellence, and we highly recommend their services to anyone seeking top-tier quality engineering support.
MMS
We were looking for a consulting company to help us with all areas of quality affairs: implementing our first QMS, requirements development, risk management and design verification planning. AlvaMed has a pulse on the size of our company and capabilities and a good understanding of how to support our timelines and resources. AlvaMed right-sized our QMS by considering our internal and outsourced activities. AlvaMed’s experience was invaluable in anticipating needs before they became critical and stepped in as needed with varying levels of support. I would highly recommend AlvaMed to any medical device company.
MVS Surgical
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.
CASE STUDY
If you need to bridge a skillset gap or just need extra bandwidth, AlvaMed has resources who can help you perform virtually any QMS related activity. We can right-size our level of support to match your needs.
We are experienced at embedding within companies to perform QMS activities. We take the time to train to your procedures and work with your personnel to ensure we are able to meet your specific expectations.
Having external resources in quality roles can promote an unbiased, independent approach.
Ready to learn more about how AlvaMed’s QMS Administration support can help your company?
Schedule time to meet with Jon Saltonstall. Jon and his team routinely partner with clients to help them keep their QMS running in an efficient and compliant manner. The team at AlvaMed is highly flexible and can provide as much, or as little, support to help you achieve your QMS compliance objectives.
