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Regulatory Affairs and Quality Management for Medical Devices

Gasværksvej 30S,
9000 Aalborg,

medicQA provides quality management and regulatory affairs consulting services for manufacturers of medical devices such as in-vitro diagnostics (IVD), drug-device combination products and software as a medical device (SaMD).

The company’s expertise spans process and product compliance tasks, including project management and regulatory affairs consulting for market registration.

medicQA implements quality management systems (QMS) and provides support during audits and inspections.

Quality management systems for the medical device lifecycle

medicQA is experienced in establishing and maintaining quality systems that comply with relevant regulatory requirements from the International Standardisation Organisation (ISO) (ISO 13485), the US Food and Drug Administration (FDA), and Revision 5 of The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.

The company’s quality systems follow current good manufacturing practice (cGMP) without unnecessary overhead, for example by combining agile software development practices with ISO 62304 compliance.

When regulatory requirements change, medicQA provides gap analysis to ensure compliance.

medicQA also prepares medical device manufacturers for audits and inspections. Its trained ISO 13485 lead auditors execute internal audit programmes, support Medical Device Single Audit Programme (MDSAP) audits, and help manage inspections by authorities such as the US FDA and the Korean Ministry of Food and Drug Safety (MFDS).

Regulatory affairs and market registration for medical devices

medicQA’s wide range of services support the market registration of medical devices and IVDs.

The firm’s experienced consultants review technical files or submission dossiers to ensure they are optimised for submissions such as 510(k), premarket approval (PMA) in the US, or CE marking under the EU Medical Device Regulation (MDR) 2017/745.

medicQA works closely with its customers to prepar documents such as risk management reports and clinical evaluation reports.

Project management for medical device development

medicQA’s project managers oversee the challenges of medical device development by coordinating numerous internal and external stakeholders such as notified bodies, third-party test laboratories and one or more subcontractors.

About medicQA

Based in Aalborg, Denmark, medicQA provides regulatory affairs and quality management consultancy services to enable customers in the life science industry to bring medical device and pharmaceutical products to market.

If you are interested in creative compliance solutions, please use the form below to send medicQA an enquiry.

medicQA A/S

Gasværksvej 30S

9000 Aalborg