FDA-ISO Quality Systems
- Our PDF-based Quality Management System (QMS) has undergone thorough examination by FDA inspectors, FDA Washington DC personnel, and a multitude of EU Notified Bodies. This ensures your business has a proven quality system primed for audits.
- Choosing our paper-based system is a cost-effective move that spares you from having to master new software or contend with business disruption due to software malfunctions.
- Wake Pharma has a strong record of helping clients secure EU MDR, ISO 13485:2016, and MDSAP certification and facilitating success in 21 CFR 820 FDA audits.
- Our team of professionals has expertise in establishing and defending quality systems for various organizations, from global Fortune 100 companies to startups seeking FDA approval and certification from Notified Bodies for their initial products.
- We take a direct, active role in quality system management and adapt the QMS to your business by seamlessly integrating your existing work instructions and procedures.
- We can create Design History Files, Device History Records, and Device Master Records, undertake validations, and perform risk analysis.
- Our robust support team enables a swift setup process to have you operational within two to four weeks.
- We’re committed to providing training, continuous support and ensuring your system can scale with your company’s growth.