Quality Management System Consulting for Medical Device Companies
The FDA requires medical device companies to follow cGMP requirements and implement a Quality Management System (QMS) that demonstrates 21 CFR Part 820 compliance. This includes regulations for developing, manufacturing, packaging, labeling, storing, installing and servicing medical devices intended for human use. Complying with FDA Quality System (QS) Regulations ensures your product consistently meets regulatory requirements as a medical device manufacturer.
MethodSense offers a wide range of Quality Management System (QMS) Consulting Services for Medical Device Companies:
- FDA Quality System Regulation (21 CFR Part 820) consulting for medical device manufacturers
- FDA GMP consultants for Quality System development and implementation
- Quality System internal compliance audits
- QA and RA due diligence audits of medical device products and companies
- FDA GMP audits for QSR 21 CFR Part 820 for medical device companies
- ISO 13485 consultants for global Quality Management System compliance
Achieving an auditable standard of quality is a significant challenge for medical device manufacturers. We focus on enabling our clients to achieve the required levels of product quality in a way that delivers both operational excellence and an accelerated achievement of your goals with practical, implementable solutions.
We also know firsthand that the most difficult aspect of compliance is maintaining it. Every year – every month – every week, there are actions that must be taken to demonstrate you’re in compliance with your Quality System. MethodSense can be part of your virtual quality team to ensure your auditability. Learn more about our On-Call Quality Support services to see if they are right for you!
Why are we the best in providing Quality Management Consulting for Medical Device?
Method Sense has knowledgeable in-house consultants with substantial industry expertise, detail to attention, and sharp analytical abilities. They can handle and complete high-complexity projects that require deep functional expertise. We focus on quality service and deep attention to our clients’ needs and business requirements. We know the medical device manufacturing industry well, including its rules, regulations, policies, and standards.
Regardless of the size of your company, we offer unique and personalized services to all our clients. We do not leave room for any complaints. All our experts are extremely accountable and experienced to understand and handle all your business needs. We believe in building strong work relationships so that we can work with you for the long-term.
Our reputed Clinical Quality Assurance programs include audits, clinical trials, regulatory mockup inspections, development, implementation, and training our clients on quality assurance best practices.
Further, our programs include clinical project management, virtual QA services, and GCP training, to offer all our clients the best and seamless clinical quality assurance experience.
Our in-depth and expert domain-level knowledge will help you stay compliant by implementing FDA compliance strategies and tactics. These strategies include implementing GXP quality systems and related compliance measures to enable your business to function without fearing any FDA warning or court proceedings.
The integration of AI into medical technologies has changed the old rules for good. Medical science and medical device manufacturing are evolving at a fast pace. All our services, skilled and trained experts, work on cutting-edge tools, and keep themselves updated. They adapt to the latest industry trends to offer you the most updated, modern, and reliable services and support.
We value your privacy, safety, and security and take all the necessary and precautionary measures to keep your sensitive personal and business information secure. We use state-of-the-art cloud technologies to encrypt and store your data. And we never share your information or any details with third parties for any reason.