Building Quality Management System (QMS) consists of clearly written and routinely regulated guidelines and requirements that form the foundation for all procedures in an organization. A successful QMS outlines the key steps for processes and generates preventative measures in a timely way to ensure that the brand, organization processes and stakeholders’ interests are protected. A […]
A Basic GMP Audit Guide The Food and Drug administration sets strict industry standards to protect and advance public health by helping to safely and effectively speed innovations and ensuring the safety, efficacy, and security of medication, biological products and medical devices. Organizations are responsible for meeting these standards and passing the Good Manufacturing Practice […]
View one or all of the 4-part med device development webinar series presented by Don DeLauder and hosted by Maria “Cristina” Muise, MBA, Ph.D., MBA, Ph.D. About the Presenter The webinars are presented by Don DeLauder. Mr. DeLauder is an expert in medical device development with over 25 years of experience in the field. He also has 14 […]
The tough part for the medical device industry is that this landscape of regulations is constantly changing. The European Union’s Medical Device Regulations (EU MDR) came into effect on 26 May 2021 after a three-year transition period, is no exception. The EU MDR (formally, EU MDR 2017/745) replaced the EU’s Medical Device Directive (93/42/EEC) and the […]
Data migration is the transfer of data between different types of storage system, databases or file formats which could involve data mapping and re-formatting. This should not be mixed up with data integration which is the process of combining data from multiple sources into a single dataset. It is commonly used when an organization needs […]
Why to Avoid an In-house ERP Implementation
ERP Integration
Cybersecurity
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ERP management
