Background and Problem
A small start-up with limited resources needed assistance with conducting its required internal audits to maintain compliance with quality and regulatory requirements. The scope of the organization’s quality management system includes ISO 13485:2016 and 21 CFR Parts 820, 803, & 806. Due to the size of the organization and the operating mode, their focus was on product development and launch, which represented a challenge for them to complete other quality and regulatory tasks with not only the expertise needed but also within an appropriate timeframe.
Approach
AlvaMed has resources on its staff that span a wide range of expertise in those quality and regulatory areas. Whether it be US or global regulatory knowledge, AlvaMed has employed the right people for both consulting and auditing. In order to fulfill the client’s needs, AlvaMed:
- Collaborated with the client to understand their scope of work
- Worked with the client on their schedule
- Ensured that the proper preparations were taken to prepare for a remote working environment
- Provided a plan and recap of results to ensure the client was aware of the phases of project completion
Results
AlvaMed ensured a successful product delivery to the customer by:
- Maintaining open communication with audit participants to prevent misunderstandings
- Providing timely feedback to management to ensure the milestones were reached
- Adhering to project timelines and reporting results efficiently
By providing this comprehensive audit, AlvaMed partnered with the client to help maintain their quality process and assess any gaps in regulatory compliance, demonstrating the significant impact AlvaMed’s assistance has on a medical device manufacturer’s success.
Key Takeaways
- Seek Expert Guidance: When resources are strained and expertise is at a premium, rely on a full-service organization with a proven track record of success.
- Choose a Trusted Partner: Ensure the team you select for quality and regulatory tasks is qualified, competent and attentive to your needs.
