Quality and Regulatory Project Management

Quality and Regulatory Project Management

To be profitable, medical device companies need to introduce quality products to the market as soon as possible (and keep them working and marketable long term) while staying on top of the evolving medical device regulations and quality controls. That’s where working with the right quality and regulatory project management consultancy helps.

Waddell Group’s experienced consultants and project management experts have helped medical device companies across the globe stay on top of current quality and regulatory management issues and future-proof their company by identifying the gaps in their current system and putting effective safeguards in place.

Managing quality and regulatory projects is not only about compliance with the applicable regulatory bodies, but also about how these requirements affect your company’s future and products in the market. There are also a lot of complex moving parts to follow and manage.

From filling out the paperwork and managing clinical trials to leading audits and conducting remediation, the right regulatory and quality project management consultants can navigate your internal teams through complex areas with ease.

Our Proven 4 Step Framework Will Help Your Team Stay on Top of Regulatory and Quality Requirements

We customize our project management framework for quality and regulatory requirements to your company’s unique problems and challenges.
Step 1: Identify the Key Challenges Facing the Company

We conduct a thorough GAP analysis to understand where your company currently is compared to your plan for it and what is needed to bridge that gap. It involves analyzing data to see if your company’s current quality and regulatory systems can match with or apply to the latest regulatory and market needs. It often involves a cost-benefit analysis to determine how the necessary changes would impact your company margins, ongoing projects, vision, and mission in the long run.

Step 2: Create a Comprehensive Quality and Regulatory Project Plan

Once we identify the necessary quality and regulatory changes needed in step 1, we create a comprehensive project plan to bring about those changes while keeping track of the associated costs, risks, and your company’s business needs. This plan considers every factor involved, including all the personnel, information, teams, and resources needed for its execution.

Step 3: Execute the Plan

After pulling in all personnel central to executing the plan, our expert consultant leads the quality and regulatory management team with trust and confidence. We focus on creating teams that are flexible enough to handle the changing requirements without it impacting their current projects. Along with the necessary training resources that work well after our consultant’s work is done, we ensure additional components don’t get added to the existing plan without first considering the costs required.

Step 4: Analyze and Reflect

Once the plan is in place and being executed, we continuously gather data and analyze it to determine the plan’s efficiency and how effective it is at delivering results. We determine if the new system is working as intended and will send the appropriate feedback to management while identifying changes to be made (if any) to systems and processes for better results.

From MDSAP, MEDDEV, ISO 13495:2016, to MDR, we train, manage, and lead teams to establish project and quality management systems and compliance that’s proven to bridge the gap between what’s required by the regulatory bodies and what a company needs.

Our project managers and consultants:

  • Are masters in the technical abilities required to effectively lead in the industry.
  • Have the regulatory capabilities, thoroughness, and patience to work through each requirement that the Regulatory Body imposes.
  • Know how to lead teams, manage with calm in times of transition, and influence for change.
  • Have at least 10 years of experience in the medical device industry across various specialties.

Find out how we reintroduced a company’s flagship product back in the market after a recall.

Our team of experts ensures that your quality and regulatory requirements are met without compromising your goals and visions for your project.