The Importance of ISO 13485 Standard

Being ISO 13485 certified helps consolidating business and employees’ trust, an essential requirement in the medical device manufacturing industry. ISO 13485 has become the worldwide accepted standard in medical manufacturing industry and certifies the conformity to regulatory requirements. Organizations in the industry are expected to provide proof for quality management system implementation throughout the entire production cycle. This is why getting ISO 13485 certified is so important.

ISO 13485 certification guarantees the conformity to international standards throughout all phases of medical devices’ life cycle: design, manufacturing, installing, technical assistance and sales. This QMS standard also covers other post production aspects like storage, distribution, provision of associated services. Furthermore, disposal and decommission of used/damaged medical devices is regulated by this ISO.

This standard is based on the ISO 9001 QMS standard, adapted for the medical device manufacturing environment. Being certified for both standards ensures competitiveness, transparency, effectiveness and will only bring more trust to potential business partners.

For manufactures, the certification means expanded market access. Being able to work with a worldwide network of potential customers and business partners is one of the top reasons why any company should require certification. National and international regulatory authorities prefer manufactures with a third-party audited and certified quality management system in. Investing in such a system speeds access into those countries that require it. Expanding production or sales operation to a new country with this QMS is difficult and in some cases, impossible.

Investing into implementation and recognition of ISO 13485 has the potential of saving a lot of money. First of all, by providing proofs for meeting high quality standards, finding potential customers takes significantly less time. All major companies which buy medical equipment require credibility and commitment to qualify for all business partners.

Although this standard does not emphasize the need for continual improvement, pointing strictly to meeting the quality requirements and achieving customer satisfaction, implementing it the company will get process control which will allow it further development and improvement.

The latest version of this ISO highlights more the need for effective risk management and risk-decision management. Risk management of any medical device must be fully documented and applied during the entire life-cycle of any product. Proving that the risk was fully understood and documented will help companies get not only ISO 13485, but also ISO 14971, which is the ISO standard for the application of risk management to medical devices.

US Federal Regulatory Compliance Made Easier – Know Your Agency

Saving time, money, intangible corporate resources and even ‘Machiavellian Litigation Entanglement’ can be maximized if the Corporate Counsel will take the time to make the investment and build relationships with US Regulatory Agencies. You may find that the US Agencies aren’t as far removed and unknowing of the everyday regulatory problems that many Corporations are experiencing as one may think.

Today’s Regulatory Environment – What’s This? A Subpoena!!

This is an area that is critical to today’s complex Regulatory scheme. Even though the new Administration has vowed to drastically reduce these regulation burdens it really does not affect a corporation’s perspective and a need to develop a CRP (Corporate Regulatory Philosophy) in the approach, management and strategy in maintaining satisfactory compliance.

It doesn’t matter whether you are dealing with the USDOJ, The Department of Commerce (DOC) which controls Import and Export (BIS), The FDA (which also includes “Stem cell” research and practice), FTC, FCC or any other Agency you must “Know your Agency” because they each have their own distinct internal procedural policies and differing aspects of Enforcement and it varies and encompasses the spectrum from highly conciliatory to what many might view as ‘Draconian” and penal in nature.

If you are involved in significant Washington, DC Agencies it is helpful to have local DC Counsel but my experience has proven that this is simply not enough. The Company’s corporate Counsel must him/herself be familiar enough with not only the inner workings of the particular DC agency but must also be able to self- Represent their Corporate interest before these agencies in any Jurisdiction.

To this end it is advisable to be a familiar name and face with these Agencies and my approach is to make frequent visits and learn the personalities behind the Titles, develop the relationships and reputation with these individuals and this is the difference between getting a phone call from them in advance as opposed to a Subpoena.

Why Travel to DC – Because as a practical matter these agencies hierarchies do not return phone calls very often and even when they do it doesn’t result in much progress but they WILL entertain a visit to their offices where they feel at ease and comfortable (even though the corporate Counsel may not -at first).

For that reason I make it a routine part of my practice to visit, conduct meetings and gain a first- hand knowledge of the individuals and what their Agency considers their priorities on any given issue and time.

Enforcement – Depending on the Agency the regulatory authority will be different and it is critical to know this information. Some agencies rely exclusively on the Department of Justice which is an enormous and politically motivated entity and so having DOJ experience will without a doubt produce great results.

DOJ -The DOJ can be painstakingly slow, non-responsive and bureaucratic but having a relationship with the Assistant Attorneys General can drastically reduce this onerous impediment. They can also be heavily influenced by penalty enforcement and some have argued that this indigenous Agency element is controlling and unfair.

It is easy to reach this conclusion (like the $8 Billion penalty that was assessed to a foreign EU bank) but it is also true that knowing the Agency, the Personalities behind the Titles and *especially having both a rapport’ & reputation of sincere “corporate citizenry” responsibility will nonetheless be invaluable for while there are serious civil and criminal availabilities that are at the Prosecutor’s disposal there is also a wide margin of discretion & power allocated to these individuals and at the end of the day I have found them to be understanding and fair minded individuals that live and have the same daily activities as we all do.

It would come as a surprise to most Corporations to learn that within the past three years I have been told by the USDOJ, FDA & the Securities Exchange Commission that I was the first ‘In House” Counsel that had ever visited their office and that they almost exclusively dealt with the Same local DC Counsel.

Internal Enforcement – At the other end of the spectrum we have Federal Agencies that have their own internal Regulators and Enforcement Attorneys. For example:

The Federal Communications Commission or the “FCC” – Ever since the 2015 reclassification of Broadband communications (the internet) has fallen into this Agencies Title II & Title III jurisdiction it has grown in immense authority and jurisdiction and this involves even “remote” or “short range” devices such as Bluetooth, cordless control of appliances and the like and there is a plethora of regulatory activity regarding such “FCC Terminology” as “unlicensed spectrum” or falling what is known as the “white spaces” which (remarkably) both Google & Microsoft is seeking to achieve.

Within this Internal Enforcement group also includes the CPSC or Consumer Products Safety Commission together with the Federal Trade Commission or FTC which derives with their original 1914 Clayton Act jurisdiction of “Unfair Trade Practices”. Now, this Agency is located in Bethesda Maryland and is comprised of only 500 employees and has two internal Enforcement Agencies – the OIG (Office of Inspector General) and the CLU (Criminal Liaison Unit).

Now, this is critical to know how these internal agencies operate as opposed to the DOJ and it can make the difference between an enormous fine + penalty and a relatively painless Consent Decree whereby the company agrees to engage in corrective behavior within specified guidelines and I can attest that this Agency can be incredibly wonderful to work with and to establish regulatory official relationships because believe me when I say “They Call The Shots” in their territory.

Department of Energy -DOE – I would be remiss in discussing these limited agencies without touching upon the DOE. Within this enormous agency is the FERC or Federal Energy Regulatory Commission and this jurisdictional base is massive – Coal, Wind, Solar, Nationwide Power grids, Geomagnetically-induced currents (GICs), GMD or Geomagnetic Disturbances, maintenance of the Nuclear power plants, hydroelectric power… “whew! I could go on forever but the important thing to note here is that this area of power regulatory schematics can be complex to the point of seeming almost Algorithmic and it is true that they can be complex and controversial (See 1., below) But I can state with experience that this agency has a very “compassionate personality” when it comes to enforcement. They simply want the job done.

They do not have the time nor desire to perceive themselves as a “tax alternative” Agency for their responsibility is quite frankly far too important and critical to both our domestic welfare as well as our National Security and they well recognize this responsibility 2. In recent times they have found themselves at the crossroads of the Public Welfare, Homeland Security, GEOINT (Satellite Surveillance) and as a cross functional agency with numerous others.

Know When To ‘Stand Your Ground’

Strategy When Things “Go South” – All said here in this brief synopsis are the highlights and points of interest in knowing the Agencies, their particular enforcement policies & procedures, whether it be internal or external (DOJ) and perhaps most importantly building the relationships.

But what does a Corporation do when they have become the “target” of an Agency and diplomacy and remedial action has proven to be no avail and it appears that the Agency is unduly aggressive and seems intent on strict and unreasonable and/ or severe fines or penalties. This is rare but it does happen.

This is when the Corporate counsel needs a “pre-advance” action strategy in place to deal with these to adequately protect the legal and financial interests of the company. One Option is to make sure that you maintain your “Home Playing Field” and that means filing an action in the Federal District Court in YOUR particular jurisdiction and seek remedial, injunctive or declaratory Relief vs. the impending Agency action and it is just as important to note that having a reputation that your company can and will take such steps is a great deterrence against such action.

The Agency knows that if they are to compel you to appear before the “Ever So Friendly” Court within Washington, DC that your chances are slim. It’s like playing against the house in Vegas. Some corporations have argued that the deal is stacked.

But what would you perceive to be your chances if you were to hail that agency into a Federal Court in, say, San Antonio or El Paso Texas? I’ll let you decide that for yourself but take my word that your chances of conciliation are far greater in the Independent Republic of Texas in a Dallas Federal Courtroom that they are on Pennsylvania Avenue 7 blocks away from the White House and the DC Enforcement Attorneys know full well that the Federal Courts in Texas have no fear of the Washington power base and have and will consider its Corporate citizens.

Now, be it not said here that the DC Courts are not fair and I mean to infer noting disparaging against that venue but the reality is this: There is a Political, practical (less expensive) and undeniable advantage of a jurisdictional home Court advantage and it should be common knowledge that if the Corporate entity feels that it is appropriate that it will indeed take full advantage of their home State venue- This is simply and ethically appropriate legal strategy- so use it!

1. For example there is a provision in the Federal Power Act Section 215(e)(3): which states: The FERC may order compliance with a Reliability Standard and impose a penalty if a BPS user, owner, or operator “has engaged in or is about to engage in any acts or practices that constitute or will constitute a violation of a reliability standard”

2. Electric Power Grid Disasters- March 1989 blackout in Quebec Damage to Salem (NJ) generator step-up transformers (1989) October 2003 “Halloween Storm” 1859 “Carrington” event

Hi, my name is David W. Hutton, Esq. I’m excited to share my insights and strategies with you regarding the Law in the age of AI and technological advances that are exponentially transforming the very fabric of our lives and how we do business. It is an exciting time for those who are prepared to stay ahead of these advances. Subscribe and stay in touch. I also look forward to your comments so please share.

As a former Chief Counsel of two $1B Corporations, a Foreign Global Compliance & Transactions Counsel, A Government Chief Prosecutor, An Intelligence Prosecutor -Asia and a Multi-Jurisdictional Litigator. I possess the capability to quickly identify and assess risks, compliance thereto and formulate and execute mitigation plans with a strong presence of credibility to present to and advise the Legal and Corporate Affairs with persuasive communication and influencing skills. The ability to build relationships and work efficiently and effectively across a matrix organization. Data Privacy – What’s in there and what do you do with it? AI, Dark Data, etc.

Quality Management Systems in the Aviation Industry

“Ad Astra Per Aspera” is a very well know logo, representing the human desire to reach the sky. From Da Vinci’s sketches to today’s passenger planes and space stations, the humanity has reached a hard and complicated road. Now you can board a passenger plan and reach wherever you want. This would not be possible without the strict safety regulations of the aviation industry. In order to make sure that all safety measures during manufacturing and delivery process are met, an ISO standard has been developed and its implementation and certification is required in the aerospace industry. Find out more about AS9100C certification and its benefits.

AS9100 standard highlights the requirements for Aviation, Space and Defense Organizations. The standard includes all of the elements of ISO 9001, as well as additional requirements specific to the aerospace industry. The recent C and D revisions stress out the importance of effectiveness during manufacturing processes. All processes must be well documented and a high quality product must be delivered within the timeframe expected by the customer. During audits, these documents will be shown to auditors. AS 9100 Rev C standards require the marking and coding of items in order to meet compliance standards. All manufacturers that provide products for the U.S. Departments of Aviation, Space, or Defense must be AS 9100 certified.

Implementing this QMS ensures that the company is focused towards quality goals, while not sacrificing productivity rate and process effectiveness. In fact the whole purpose of this QMS is to insure a productivity increase, a better connection with the supply chain.

Counterfeit parts prevention was stressed out in the latest revision, by implementing new clauses. New clauses regarding tracking were also added. Since AS9001 Rev C, the products supplied to the aviation industry should follow procedures similar to UID marking and coding procedures with. The manufacture must have automated data capture capabilities for all phases of production from distribution to maintenance. This makes sure that whenever an audit or technical inspection is undergoing, all documents will be analyzed in order to detect process flow deficiencies and repair them.

Aeronautic and defense industries leave no room for mistakes. Any mistake on the ensemble line will significant delays, which translate in many millions of dollars lost during the whole manufacturing and distribution process. AS9100 standard emphasizes the risks and the need for safety management, including behavioral training of the workers (to respect all safety requirements).