Don’t Let ISO Remediation Catch You Unprepared
If you work and breathe medtech or med dev, you’re all too familiar with the International Organization for Standardization. Otherwise known as ISO, this is the organization responsible for ensuring medical device manufacturers are developing quality management systems that abide by strict standards. ISO standards help dictate specifications, design, development, manufacturing, clinical standards and more for all devices flowing through the medtech industry.
The list of ISO standards is expansive and can be overwhelming—especially if you’re heading a medtech startup. QuickConsult is your source for experts to help you hash everything out. Even if you’re a seasoned medtech vet, you may just need a supplemental ISO expert to help you out. Instead of enduring a long and costly hiring process, coming to QuickConsult ensures you’re only meeting expert candidates who can be hired for one question or a long-term project. The duration of help you receive is totally up to you and you can always rest assured you’ll be getting help from some of the best brains in the business.
QuickConsult is your key to access to experts in all facets of the medtech industry—including ISO remediation. From ex-FDA to VPs of Fortune 500 companies, our pros have been there and done that. Whether it’s preparing for an audit to ensuring Good Clinical Practice (GCP), we can help navigate you through the murky waters of ISO. Pairing with QuickConsult means you can choose from select experts right away and get answers quickly. This saves you valuable time and money by eliminating a prolonged hiring process and the time you would have to wait spend researching an answer or solution on your own.
QuickConsult’s Areas of ISO Remediation Expertise
While our experts can help you with all the components associated with ISO—including developing a quality plan—here are just a few of our more common questions.
Stage Inspection or Audit Prep
Stage inspections and audit preps can seem daunting but not with the guidance and know-how from our experts. Inspections can include digging into your QMS implementation, facility, staff’s competence, critical suppliers, and more. Furthermore, prepping for an audit, unannounced or announced, can seem equally intimidating. While audits may strike fear into some, QuickConsult experts can help prepare you so they are the least disruptive as can be. We can help you figure out what documentation to have in place and what processes to follow. By homing in on exactly what you should have ready for inspections and audits, you can always have the peace of mind that you are prepared.
Resolution of Findings
If issues arise during your inspection or audit, don’t stress. QuickConsult experts can help you resolve any findings that may have come up.
This standard pertains to all stages of a medical device’s life cycle. For a manufacturer, this standard requires the hazards associated with medical devices to be identified in order to evaluate and control risks while monitoring the effectiveness of the controls.
ISO 13485 applies to all medtech companies regardless of its size. This standard outlines the requirements for a QMS to demonstrate its ability to provide devices and services that meet customer and regulatory requirements. The organization needing to adhere to ISO 13485 could be involved in one or many stages of a medical device’s life cycle. Whether it be development, production or even installation of a product, ISO 13485 requirements must be met.
ISO 15189 is specific to laboratories. This standard isn’t just for ensuring a clinical lab has an established QMS, but it also can be used for recognizing its competence by lab customers, regulating authorities and accreditation bodies. This standard helps ensure all clinical practices are following the quality of standards, which leads to better overall quality of care. Is your lab abiding these standards? Let QuickConsult help you.
Good Manufacturing Practice (GMP)
Much like it sounds, GMP means following requirements in regard to the methods employed and the facilities used for designing, manufacturing, packaging, storing, etc. medical device. After all, establishing and following your quality systems equates to diminishing the chances of having to recall a product or resolve costly problems in the future.
Good Laboratory Practice (GLP)
We can help you establish quality management systems for your research and clinical labs. After all, ensuring the consistency, reliability and quality of your processes and devices means success for you and quality care for patients who rely on your product.
Good Clinical Practice (GCP)
You may have a lot of questions when it comes to clinical trials involving humans—that’s where we come in. Experts at QuickConsult can help you establish and abide by GCPs. Good clinical practice involves international standards that involve designing, conducting, recording and reporting any trials human subjects are involved with. These standards help enforce quality and ethical standards are met globally.
If You Need ISO Remediation, You Need QuickConsult
Our experts have worked with a wide variety of notified bodies, and we can help you prepare for audits and respond to observations in a timely and clarified way. We can save you time, money and headaches by reducing the worry you could face when confronted with any number of ISO problems. Our experts work remotely, which means they don’t have to abide by the physical limitations when it comes to helping you. If you have one question you need answered quickly or if you have a long-term project you need a supplemental expert for, QuickConsult is exactly what you’ve been looking for. Let’s get your quality systems in place, pinpoint areas of focus, and start answering any and all questions you might have about ISO remediation so you’re prepared for anything that comes your way. Start asking your questions today so you’re prepared for whatever could happen tomorrow.
“QuickConsult is like having a really good friend who’s a really good expert, in your back pocket, that you can … ask a tough question! [QuickConsult] provides that network in a way that is easy access, vetted people in an environment that you can trust and be protected. I think that’s invaluable.”
– Susan Alpert, MD, PhD, former Medtronic SVP
Ask your ISO Remediation question now