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.
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.