Regulatory and Compliance
How we do it
MAS Connections understands the importance of regulatory compliance in various industries and the impact it can have on business operations. Our Regulatory and Compliance service helps businesses to comply with industry regulations and standards by providing a comprehensive review of current processes and identification of any gaps in compliance.
Our team is experienced in FDA and ISO 1901 & 13485 regulations and can provide recommendations for the development of QMS Compliance/Quality plans to ensure compliance. We also specialize in process documentation, including the creation of Standard Operating Procedures (SOPs) and validations such as Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Additionally, our team can assist in preparing for FDA and ISO audits, ensuring that your organization is audit-ready and prepared for any regulatory inspections.