GMP / ISO 13485

Implement GMP / ISO 13485 to improve your business KPIs

100% of our clients have successfully passed ISO certifications and Cybersecurity compliance since 2000.

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GMP / ISO 13485

We build

a clear, effective system that reduces risks, prevents defects, and ensures stable compliance with regulatory requirements.

Handle 95% of the work

from analyzing existing processes and proper documentation to implementing new workflows.

Move

as fast as your business needs. We prepare companies for GMP compliance and certification in 12–18 weeks.

ISO 13485 is the standard for quality management systems in the medical device industry, ensuring companies meet safety and regulatory requirements. It emphasizes risk management, lifecycle control, and compliant processes for the design, production, and servicing of medical devices.

Who we help

Small and growing medical device companies implementing ISO 13485 for the first time

We help when:

processes exist but are not documented;
there is no formal risk management and everyone relies on personal judgment;
regulatory requirements feel overwhelming.

We build the system from scratch, set up risk management, create clear documentation, explain the standards in simple terms, and integrate them into the team’s daily work.

Companies with many processes that need optimization

We help when:

here are numerous procedures that don’t work in practice;
the company receives frequent nonconformities from auditors;
the team struggles to handle customer complaints effectively;
you need to quickly prepare for a strict upcoming audit and remain ready for any future audit.

We streamline the system, reduce documentation volumes by tens of times, and make it easy for the team to use.

We prepare the company for any auditor — even the strictest one.

About us

We will guide you through the entire process so you can achieve certification on the first attempt

The medical field is highly regulated. A company must not only comply with ISO 13485 but also follow specific CFR requirements and other regulatory obligations. If the business works with packaging — one set of requirements applies; if it deals with implantable medical devices — another. There are also additional requirements for cleanliness, process validation, and equipment validation.

Your organization must simultaneously comply with ISO 13485, FDA requirements, and GMP. We’ll be by your side throughout this journey and make it as simple and clear as possible. We’ll guide you through every step, explain what to expect, what needs to be done, what you are required to do — and what you don’t have to do.

Frank Yazhari

Founder and Managing Partner of FY Consulting

Frank Yazhari

25% of the payment is made only after successful certification.

New system will work effectively
for your business for years

We will organize your documentation and risk management

Teams that come to us already work with attention, accuracy, and responsibility. They are client-oriented and trust their teams. But in the medical industry, this is often not enough: without a formal risk-management system, every employee may rely on personal judgment, which increases the likelihood of mistakes and nonconformities. We help set up these processes so your business can achieve certification and operate more stably and predictably:

identify risks across all key processes;
create clear and easy-to-follow instructions and procedures;
organize verification and validation of equipment and processes;
train your team to assess situations not intuitively but according to the standard’s requirements;
build a decision-making system that your entire team can rely on, a common quality standard for your business.

We will implement corrective actions that reduce the number of issues

One of the key elements of ISO 13485 implementation is proper handling of incidents, nonconformities, and customer complaints. Problems tend to repeat when there is no clear process for identifying root causes. We teach teams to:

determine root causes rather than just eliminate symptoms;
carry out effective corrective and preventive actions;
document and analyze incidents so they do not recur;
report to regulatory authorities on time and in the correct scope to avoid fines or loss of certification.

We create a structured complaint-handling system where all complaints are logged, assigned to responsible owners, prioritized, and processed with root-cause analysis and clear actions. Preventive actions become part of the company’s daily work. As a result, the team spends far fewer resources on fixing errors, resolving incidents, and putting out fires.

What clients say

"In 2008, we were referred to FY Consulting and successfully achieved certification."

FY Consulting was referred to us by one of our competitors. it is many years later and we have never regretted the decision. We have utilized their Internal Audit (Medical Devices) services for the last 6 years. It was from 2019 that we shifted our QMS from US FDA QSR and ISO 13485:2016 to the Medical Device Single Audit Program (MDSAP) along with our ISO 13485:2016 QMS. For MDSAP we decided to comply to USA, Canadian, Brazilian and Australian requirements. We did not have enough qualified resources internally to properly fulfill our audit program but also wanted to have a ‘fresh set’ of eyes with the expertise to ensure our success. Well currently, we are still using FY Consulting and have had successful audits and a few backs to back audits with no Nonconformities. Thank you, FY Consulting for all the support!

ISO 13485

Ina Hairston

— Head of regulator affairs, DRG International

6 years in Business with FYC

Medical Device

Ina Hairston

Frank didn’t see problems, he saw solutions. That mindset, rare among consultants, made a real difference. He was consistently reliable and responsive throughout our ISO certification process. His expert guidance was instrumental to our success, and his clear, timely support helped us reach our goals efficiently. Frank’s implementation style minimized stress and significantly reduced the time required to get things done.

Frank's expertise streamlined our internal processes, leading to greater consistency, fewer errors, and reduced waste. He helped us improve our business to be able to deliver the highest quality at the lowest price. This lead to increased market share.

I worked with Frank for over 20 years and together we achieved multiple certifications: ISO 9001- Quality; ISO 16949 Automotive; ISO 13485 Medical and ISO 1400 Medical.

Frank also helped us maintain our certifications by providing annual internal auditing and risks assessment support for over 15 years.

With Frank’s support, we achieved KPI scores in the top 5% of our industry, as measured by independent benchmarking data.

IATF 16949 ISO 13485 ISO 9001

Tom Trokan

— VP, Quality Systems, Weiss-Aug, Inc.

22 years in Business with FYC

Automotive Medical Device

Tom Trokan

Rapid сertification support

We move as quickly as your business needs. We understand that key contracts and partnerships depend on timely certification, so we streamline approval processes: we won’t hold up your work while you review new procedures — instead, we prepare the next documents and conduct team training in parallel.

12–18 weeks

Timeframe to prepare a company of up to 20 employees.

What clients value in our support

We explain standards in simple, clear language so your team understands exactly what needs to be done and why — and can apply it not just for certification.

We work alongside you as part of your team, fully immersing ourselves in your processes, identifying gaps, and implementing a system tailored specifically to your business.

We are always available, respond the same day, and pick up the phone immediately. We understand how important certification is for your business and are genuinely committed to your success.

Video testimonials