Our expertise, your advantage.
What We Do
All About You
Alayamed is dedicated to supporting your medical device company in navigating and fulfilling your Quality Management System (QMS) requirements. In an era where doing more with less isn't just a goal but a necessity, Alayamed's unique blend of expertise and innovative strategies ensures your operations are not only compliant but streamlined for maximum efficiency and focused on what truly adds value. Our approach is collaborative and client-focused, ensuring that we work hand-in-hand with your team to achieve outstanding results that align with your strategic objectives. Our team, driven by expertise and a profound commitment to your success, is dedicated to delivering results that not only meet but exceed your expectations.
Our Solution
Alayamed specializes in assisting medical device companies in achieving significant time and cost savings. Recognizing the importance of not only understanding regulatory requirements but also efficiently and effectively meeting them, we offer comprehensive support tailored to every stage of the process. From the inception and optimization of Quality Management Systems (QMS) to executing specific job functions, our expertise ensures optimal outcomes. With a demonstrated history of surpassing expectations within designated timelines, our services encompass strategic guidance, team leadership, process streamlining, tool development for procedural advancement, and the adept handling of ambitious projects within tight timelines.
Our Expertise
With more than 15 years of experience in the medical device industry, Alayamed's expertise spans across quality system management, as well as quality, manufacturing, and product development engineering. Our competitive advantage lies in our ability to understand both the broad, strategic perspective and the specific, detailed aspects, while also maintaining a relentless dedication to execution. This distinctive blend empowers us to bring your vision to life with precision and dynamism.
Recent Projects
Successfully Launched First Product to Market:
- Challenge: Following a decade of development and FDA Clearance, an ex-FDA investigator identified deficiencies in Design Controls, signaling potential market withdrawal if launched.
- Project Outcome: Achieved market launch of initial products within 18 months.
- Key Contributions: Overhauled procedures and processes, identified existing work that could be leveraged, spearheaded the Design Controls Process (including writing strategic Design and Development Plans, crafting the Project Schedule, leading team meetings), and generated essential Design Control deliverables such as Design Reviews, Device Master Record, Design Trace Matrix, Master Validation Report, and Design History File.
Revitalized an Underperforming QMS Process:
- Challenge: Facing several years of backlog in incoming inspection and diminished trust in inspection results.
- Project Outcome: Cleared three years of backlog in just three weeks, achieved a 700% increase in labor efficiency, and enhanced inspection quality.
- Key Contributions: Restructured workflow (including lab layout), rewrote inspection quality system procedures, developed part inspection test methods, formulated procedures for documenting and approving automatic inspection routine designs, conducted Gauge Repeatability and Reproducibility Studies for consistency, and proactively addressed gaps in 167 part inspection files, well ahead of schedule.
Remediated FDA Audit Finding:
- Challenge: Received FDA Audit finding for not closing complaints in a timely manner.
- Project Outcome: Resolved backlog within six months (surpassing the seven-month goal) and closed post-audit complaints within an average of 20 days (exceeding the 45-day target).
- Key Contributions: Revamped all complaint-related procedures, established physical and electronic filing systems, devised mechanisms to address database constraints, implemented a log for managing returned device evaluations, streamlined workflows, and conducted investigations for over 3,000 complaints.
Expertly Managed Critical Regulatory Audit:
- Challenge: The completion of a pivotal acquisition deal was contingent upon the successful outcome of the Notified Body Audit, a situation complicated by the recent departure of the company's head of quality.
- Project Outcome: The regulatory audit was meticulously managed, culminating in a successful conclusion with no findings identified.
- Key Contributions: Conducted an exhaustive gap assessment, swiftly addressing and rectifying identified vulnerabilities within a two-week timeframe. Expertly responded to the auditor's inquiries with a combination of in-depth knowledge and assured confidence, ensuring all concerns were satisfactorily resolved.