The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
The European Medicines Agency (EMEA) has released for comment draft guidance on acceptable limits of metal residues in drug substances and excipients (inert substances that aid in binding a pill or tablet).
Philips Medical Systems is continuing discussions with the FDA over the company’s alleged deviations from current good manufacturing practices related to the production of its automated external defibrillators (AEDs), the firm told D&DL March 6.
FDA investigators found that Apple Medical’s procedures regarding its Fischer Cone Biopsy Excisors (FCBE), which are gynecologic electrocautery devices, violated several cGMP regulations, the agency said in a recent warning letter.