Audits

FDA Establishment Types

FDA Establishment Types

‌  When registering a medical device with the FDA the type of product influences the method of pre-market application...

510K Submission Tips

510K Submission Tips

‌  Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow for...

Making a Change to a QMS

Making a Change to a QMS

‌  A Quality Management System (QMS) is often designed well before a company starts the development of its...

What to Do with a Bad QMS

What to Do with a Bad QMS

‌  For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) is...

Audit Readiness

Audit Readiness

‌  Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur getting...

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