By: Robert Dean
Regulatory compliance is a complex, demanding, expensive legal requirement(s) and a never ending endeavor. There are no “short cuts” to conformity and compliance within various national laws, there is only objective evidence or proof that a medical device manufacturing company is complying with the law.
The theme of this article, “Regulatory Requirements – What Doesn’t Kill Us Only Makes Us Stronger” is indeed an accurate statement, however let’s take an alternate view that at this time to provide for an improved vision. This alternate view is “We make ourselves stronger so we don’t get killed”. Yin and Yang? Reactive versus Proactive? Complementary versus Nonreciprocal? I’ll let you decide, however please consider the following.
Almost all first world countries have legal regulatory requirements that must be complied with in order to allow medical devices (and of course other products in general) to be sold and used within those countries borders. A short list is…
- USA FDA, FD&C Act and Quality System Regulation 820
- European Union (EU) Medical Device Directive 93/42/EEC and ISO 13485
- Australia Therapeutic Goods Regulation for Medical Devices
- China (PRC) CFDA Medical Device Regulation
The overarching objective of these regulations is to prevent the national public population health to be exposed to risks and compromise and to also protect the general public from in-effective devices. This theme is consistent throughout the first world. The regulatory process to accomplish safe and effective medical devices is typically a linear process and follows this chain path;
Now within the above “chain” is where EMM makes itself stronger. EMM has conducted, documented, assessed and submitted hundreds of verifications and validations to assure devices manufactured continuously conform to established standards and regulations. EMM audits and monitors the quality performance of their own processes as well as the performance of their suppliers. EMM has in place a sustaining Quality System which complies with multiple national standards. This quality system is audited, reviewed and continuously improved to assure product and process performance (Our manufacturing operation has been audited by the USA FDA twice in the past 2 years without any significant “objectionable observations”). If there is a break in any of the links in the above chain there is an increased risk of getting “killed”. ”Killed” in the sense of product recalls, regulatory agency actions (e.g. consent decrees, restrictions), poor product sales caused by inferior product performance, and the most unwanted is harm to a patient or end user. When you learn of, read in the trade press, or hear at a trade show a company which has encountered one of these “killing events” it is usually caused by a process short cut or not understanding the regulatory requirements that could have prevented the “killer” occurrence.
In conclusion, EMM is continuously improving our quality system by pursuing additional governmental agency certifications and approvals. We also make a commitment to verifying and validating our processes to continue to “Make Us Stronger…” as a proactive approach to prevent that we “…don’t get killed”.
Biography of Robert O. Dean
As a Director of Regulatory Affairs and Quality Assurance works with customers, US Team and the China team developing and implementing quality systems and device design protocols and validations to assure specification and national regulatory compliance and certifications.
Robert has +40 years’ experience in the pharmaceutical, medical device, and cosmetic industries, focused on the areas of development, regulatory, manufacturing, quality and business management.
Robert has 5 active medical device patents, +50 governmental approvals, and world wide experience with medical device development, manufacturing and compliance.
In his free time Rob can be found hiking, riding and kayaking, preferable above 8000 feet. At sea level, exercising, surfing, competitive driving and “wrench turning”.