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Compliance Document Management for the Medical Industry

Compliance document management is highly regulated in the medical industry. BPA has developed specific tools and automated workflows to comply with medical regulations, like ISO 13485, FDA part 11, MDR and others. Document preparation area with approval eSignatures in BPAMedical365. We designed different areas in BPAMedical365 to prepare and approve documents, publish approved documents and […]

How BPAMedical365 Complies with ISO 13485 ?

Whether you are a medical device manufacturing organization, or a healthcare service provider, or even a supplier of materials or services, the international standard ISO13485:2016 requirements can be applied to establish and maintain a sound quality management system in your organization. The latest edition of the ISO 13485 standard has been released in 2016 and […]

Make Risk Management Easy and Efficient with BPA Apps

BPA modern apps for quality and medical compliance include many modules for risk planning with the objective to develop a preventive risk mindset for the organization. Our components are very flexible to adapt to any risk methodology and comply with ISO 14971 recommendations. We introduced 2 levels of risks in our software. Point risk analysis […]