Regulatory Doctor

26
Jan

Laser Photodynamic Therapy

MVF Laser Photodynamic Therapy Device: System, Laser, Photodynamic Therap Product Code: MVF Device Class: 3 Recognized Consensus Standards IEC 60825-1 (Second edition – 2007) Safety of laser products – Part 1: Equipment classification and requirements CORRIGENDUM 1 IEC 60825-1 (Second edition – 2007) I-SH 01 SAFETY OF LASER PRODUCTS – Part 1: Equipment classification and requirements, INTERPRETATION SHEET 1 IEC

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25
Jan

Product Code | LZS | Ophthalmic | Excimer Laser System | Device Problems | PMA

By Regulatory Doctor; LinkedIn; Google Plus; Twitter; Facebook Product Code | LZS | Ophthalmic | Excimer Laser System | Device Problems PMA Representative List of PMAs in 2013 under Product Code LZS NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM P970053 S011 09/30/2013 ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYST P020050 S012 09/27/2013 WAVESCAN WAVEFRONT SYSTEM P930016 S038 06/27/2013 TECHNOLAS PERFECT VISION 217Z ZYOPTIX SY P990027

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25
Jan

When a PMA Supplement is Needed | Regulatory Doctor

General Requirements for When a PMA Supplement is Needed  Examples of the types of modifications that require a PMA supplement (21 CFR 814.39(a)), if such changes affect the safety or effectiveness of the device, include, but are not limited to, the following: 1)      new indications for use of the device; 2)      labeling changes; 3)      the use of a different facility

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19
Jan

Management Consulting | Management Consultants | 360 View

Management Consulting | Management Consultants | 360 View We provide management consulting (360 views) to corporate management helping startups, young pharma, and device companies. How we do: We use our confidential and proprietary systematic assessment systems developed over the years.    We consider and use all factors for accurate and precise assessment under the circumstances. We identify root causes. We

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17
Jan

GCP for Medical Devices

Good Clinical Practice for Medical Devices FDA | GCP | Medical Devices | ASRs | LDTs | IDEs | HDE | Sponsors | IRBs | CIs | Informed Consent | 21 CFR Part 11 | HIPPA | DMC | ICH General 21 CFR 50.54, Process for Handling Referrals to FDA under, Guidance for Clinical Investigators, Institutional Review Boards and Sponsors

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17
Jan

Supreme Court of Alabama | Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling.

To Download A Copy of the Court Ruling, Please Fill Out the Form Below. [contact-form-7 id=”51″ title=”Supreme Court of Alabama Has Ruled Brand Drugmakers Can Be Held Liable for Generic-Drug Labeling.”] Copyright © 2012  Regulatory Doctor.  All Rights Reserved. This web is hosted by Hostgator.