15 Oct 2020

Beginners Guide: FDA Regulations for Medical Devices & IVDs

MDMS, iso 13485

So, where is the newcomer to FDA regulations and guidelines to begin? There are a mesmerising series of FDA Guidelines regarding the manufacture, import and/or distribution of Medical Devices (incl. in vitro Devices - IVDs) on the US Market. And nowadays there also seems to be a continuous stream of new and draft guidelines being published. So, where is the newcomer to FDA regulation and ...
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13 Oct 2020

If you manage a QMS, don't take a Lead Auditor Course!

auditing skills, certified training company, EMS, ISMS, lead auditor, lead implementer, MDMS, QMS, iso 9001, iso 14001, iso 45001, e-learning, iso 13485, iso 27001, OHSMS

You’re thinking, "But this is what Management Representatives have been doing for decades. Why shouldn't I take a lead auditor course?"
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31 Aug 2020

Do ISO Lead Auditor Training Days matter?

iso certification, certified training company, EMS, ISO 29990, lead auditor, MDMS, QMS, iso 9001, iso 14001, iso 22000, iso 45001, iso 13485, iso 27001, OHSMS, iso auditor

All auditor experience where a prospective auditor participates in a real audit is useful.  But, there is a fundamental question: for ISO management system standards, are auditor training days needed before a Lead Auditor Certificate can be issued?
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09 Dec 2019

Class 1 MDR Self-certification re CE Mark extended by 4 years

MDMS, iso 13485, regulatory affairs, MDR

The European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday voted to adopt Corrigendum 2 to the Medical Device Regulations (MDR) that will give manufacturers of certain up-classified Class I devices an additional four years to comply. Corrigendum 2 to MDR was published on Nov 25th and it modifies Article 120(3) of MDR that now reads: '3. By way of derogation ...
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11 Nov 2019

Getting the IAF Logo on your ISO 13485 Certificate

accreditation, MDMS, iso 13485

The European Cooperation for Accreditation (EA), an association of 30 national accreditation bodies in Europe, has completed the administrative requirements of the IAF (International Accreditation Forum) necessary for the extension of their IAF multilateral recognition arrangement (MLA) to include ISO 13485.  This omission has in the past, for example, been a barrier for European medical device ...
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11 Oct 2019

MDR IVDR Deadlines, Crash-out Brexit and other disrupters

MDMS, iso 13485, MDR, IVDR

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01 Aug 2019

ISO 13485 Certification for those not making Medical Devices

iso certification, MDMS, iso 13485

ISO Certification for the Medical Device Supply Chain Where do I start if I want to get Certified to ISO 13485? This is a question frequently asked by those involved in the medical device supply chain (e.g. component manufacturers and logistics companies) who have no experience with medical device manufacture. With a steady, if slow, increase in medical device companies requiring ISO 13485 ...
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03 Jul 2019

PRRC requirements in MDR and IVDR - new guidance

MDMS, iso 13485, regulatory affairs

EC Guidance regarding a ‘person responsible for regulatory compliance’ (PRRC) The European Commission has recently published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will be a challenge for SMEs and start-ups but the ...
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19 Jun 2019

The MDR and IVDR Registration Nightmare - it's getting worse

MDMS, risk management, iso 13485, regulatory affairs

  The European Commission continues to insist that everything is in place for the May 2020 deadline for MDR (2017/45) transition as well as related Notified Body (NB) designation and Eudamed database development.   Objective evidence suggests that this is ‘bunkum’.
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18 Apr 2019

EU MDR to result in withdrawal of devices from the market

MDMS, risk management, iso 13485, iso 14971

Without an immediate action, tens of thousands of medical devices will be withdrawn from the EU regulatory area next May. MedTech Europe, a European trade association for the medical technology industry including diagnostics, medical devices and digital health, have issued an open letter (dated 15th April 2019) to the European Commission on the implementation and readiness status of the new ...
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