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ISO 13485

Sell premium medical devices with ISO 13485 Certification Standard

Our unique method can get you ready for ISO certification in as quick as 30 days with no compromises.

The ISO 13485 Certification Standard for medical device companies

ISO 13485 is based on ISO 9001 with a particular focus on Medical devices (of course). The United States has the highest uptake of ISO 13485 in the world, commanding 30% of all certifications worldwide. Quite an accomplishment, and it shows that the USA is leading the way in compliance.

Most industrialized countries have some forms of medical device regulation, i.e., the US Food and Drug Administration [FDA]. Before this standard, there was no single standard to harmonize the regulations for quality management systems globally, making exporting difficult and precarious. Enter stage right ISO 13485.

Some regulators around the world directly require certification to ISO 13485. While this is not currently a requirement in the US, there is a US law that is similar in almost all aspects to ISO 13485, which is 21 CFR Part 820. Most US companies looking to send products outside of the US will also get ISO 13485 Certification.

Why Achieve the ISO 13485 Certification for Your Business?

Proving yourself as a good and consistent supplier to your customer can be improved by certification to an ISO management system standard. As the importance of compliance and satisfaction grows, you will be able to draw the attention of many customers who will not work with non-ISO certified organizations. Many organizations are finding that no matter how good their product is, customers need more reassurance; they want their suppliers to be certified. Moreover, many organizations are finding that losing even one contract can well pay for the cost of implementing good management practice and getting certified. If your management system was well documented and implemented, you just might even enjoy life a little more with the knowledge that your business is in safe hands and operated as it should.

Start your ISO journey—talk to our consultants today!

ISO 13485 Standard

Best practices that the ISO 13485 Standard promotes are:

Putting the regulatory considerations aside, implementing an ISO management system standard in your business represents good management practice, or in the case of medical devices, “Good Manufacturing Practice [GMP].” By implementing ISO 13485, an organization becomes a better bet for its suppliers. Not only have they implemented important controls directly related to medical device manufacturing, but they have also provided efficiencies and effective management through:

  • A documented approach to management
  • Policies, objectives, and planning
  • Control of documents
  • Control of records
  • Reviews
  • Internal audits
  • Product non-conformances and continual improvement

To get the ISO 13485 certification standard, your business needs to consider the following aspects:

The core requirements of this quality management system standard strictly focus on quality assurance.

 A system for quality control:

The standard asks for designing and establishing a documented quality management system. It must include a quality policy alongside objectives and a manual. The aim here is to control all the documents for the process and supply effectively.

Resource management:

The standard believes that without a stringent resource management, supplying premium medical devices would not be possible. Hence, the standard asks the management to ensure adequate arrangements of relevant resources. The resources include technical equipment, human resources, and infrastructure. The management must maintain regular monitoring and documentation, too.

Responsibility of the management:

The standard asks for the management to stay more proactive and show commitment towards the quality management system. They must ensure that quality objectives are established and awareness is generated. Their responsibility extends to defining the quality policy and reviewing the quality assurance objectives.

Product realization:

The ISO 13485 certification standard asks for effectively covering the entire lifecycle of each asset. From concept to post-production, a company must follow a structured procedure for design, development, verification, validation, and risk management.

Measurement, analysis, and improvement:

For certification and compliance, companies must practice an intensive measurement and improvement program. Through compliant handling and documentation, management can succeed in a continuous development agenda.

By attaining the ISO 13485 certification, your business may see the following potential benefits:

Your business system’s compliance with ISO 13485 can help your business open doors to unexploited national and international business opportunities. Even you will be able to enjoy a bunch of benefits, such as:

Expanded Market Access:

In most developed countries, National Regulatory authorities prefer manufacturers or suppliers that have a third-party audited, ISO certified management system. Investment in a certified management system attracts more customers around the world. In other words, certification to ISO 13485 can expedite your market entry in other countries.

Reduced Cost of Sales:

When it comes to supplying medical devices, a supplier needs to spend money not only on the manufacturing process but also on the advertisements and promotion. When you are offering ISO certified products, you don’t have any need for advertisement. The ISO mark tells all about your product. Therefore, such a management tool can reduce your costs of sales and promotion.

Improved Performance:

What do you need to gain the certification? You need a well-developed management system based on a uniform and globally accepted process control system. This certified system enables you to improve your manufacturing process as well as the quality of your products. It helps you foster a strong bond with your suppliers, business associates, and customers. As an outcome, you will find that your overall business performance has improved.

Boosted Company Credibility:

ISO 13485 is an internationally recognized standard for quality management in the medical device manufacturing and supplying industry. Certification to this standard demonstrates that your company is serious about maintaining the quality of the offered products and that you have taken the right initiatives (adherence to the ISO 13485 standard) to ensure the quality of your products.

Enhanced Customer Satisfaction:

No matter what the business is, customer satisfaction matters the most. The framework of ISO 13485 is based on a set of voluntary quality principles. One of these crucial principles is meeting customer satisfaction. You can meet customer requirements and gain customer satisfaction by reviewing the customer’s requirements frequently and updating your offerings accordingly. Modern consumers are conscious. Most of them would not entertain a supplier that is not certified to ISO 13485. Moreover, customer satisfaction helps you turn your customers into permanent and loyal customers.

Once you have learned about all the benefits of ISO 13485 certification, you may want help to get certification. You’ll need to find a consultant who is skilled and proficient. When it comes to the ISO 13485 Consultants, Compliancehelp Consulting LLC is one of the best.

Book your ISO implementation kick-off call today!

Getting started with the ISO 13485 certification procedure might seem complex to you, but our expert ISO 13485 consultants will make it easier for you with trouble-free steps.

Consultation:

In the first step, we would discuss with you the details of the ISO 13485 requirements and provide consultation to help you understand their relevance in your business and processes. Our consultants would then help you plan the next steps to meet the

criteria for successful certification within a decided timeframe.

Document Your Quality Management System:

Our consultants will help you determine the scope and objectives of your service management system (SMS). Following that, they would evaluate your existing processes to determine how they will interact with the SMS. Subsequently, they would help you to prepare a document of the processes and SMS, as required by the standard. The document establishes how your employees should execute the processes to adhere to the standard’s requirements.

Implementation of the service management system:

Once the documentation is complete, you need to provide training to the employees to ensure the SMS is practically put into place. Training is necessary to ensure the system is efficiently integrated throughout your organization and there is consistency in the roles of employees.

Internal Audit:

Our team also has expert auditors who will analyze your processes and management system to find out any inconsistencies and nonconformities. They would then provide recommendations to correct or fix those identified issues to ensure your business is fully compliant and certification ready.

Certification:

You need to apply for certification to a certification body. They would perform an external audit and get your business certified after affirming the compliance of your SMS. Our consultants will help to maintain your certification in the long run by periodically following up and performing surveillance audits.

Benefits illustration

Why Hire the ISO 13485 Certification Consultants from
Compliancehelp Consulting LLC?

Lowest cost

We deliver a lean, custom fit ISO compliant management system, saving significantly on the often-overlooked, but usually most expensive part of ISO compliance- the implementation stage.

Speed

Everybody knows how lengthy an ISO certification process is! It is difficult to be motivated and focused if certification takes too long. Don’t worry! We can help you gain certification within 30 days, or often in less time than that!

Resources to obtain and maintain certification

ISO compliance does not need to cost a lot to maintain! We minimize the need for internal resources with a lean and compliant ISO quality consulting approach.

Ongoing support

Compliancehelp Consulting LLC can help you manage ongoing compliance on your own, or you can team up with us. Our personalized ISO certification services include monitoring and internal audits as well. Our experts can monitor your Quality Management System to ensure consistency, improvement, and compliance. We can also help in making it compliant with future updates to the ISO standard a cinch.

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Frequently Asked Questions

What is the ISO 13485 certification standard?

ISO 13485 certification standard is the official quality management standard for the medical device manufacturing/supply industry. The standard is internationally acclaimed for offering a relevant set of clauses. Companies can show commitment and dedication towards customer satisfaction by delivering premium devices through the standard.

What is the cost of getting ISO 13485 certified?

The entire cost of getting ISO 13485 certified depends on several factors, like the size of the company and the present state of operations. It can range from $15,000 to over $100,000, depending on the number of employees and management operations involved.

Why should I get the ISO 13485 certification standard?

With the support of a quality management standard like the ISO 13485, companies can acquire more customers through positive brand establishment. A company can enjoy customer satisfaction, its loyalty, and a steady revenue margin while getting ISO certified. Also, exposure to the international market is an added boon.