ISO 13485

Medical Devices –
Certified Quality Management System

When an organization participates in Design and Development activities for medical device products, it shall operate under a Quality Management System.

Learn more about why Pro4People has chosen to obtain ISO13485 certification.

Pro4People’s Offer for
Medical Device Manufacturers

We support our clients in Design and Development activities related to the development of software for medical devices. Our standard offer here is IEC 62304 compliant software development for any software safety classification: A, B, C or their US equivalents. We deliver such a service by providing fully staffed, self-managing software development teams. From the Client’s side, the minimum prerequisite is Product Manager’s involvement as a project stakeholder.

Software Development

Here we use IEC 62304, ISO 13485, and ISO14971 compliant Software Development Life Cycle. The Design and Development project is usually executed under Pro4People Quality Management System, which has been certified for that purpose with the requirements of ISO13485 standard.

In this area we follow Agile/Maturity approach, which enables the adaptability and exploratory nature of Agile methodologies enriched with already proven and continuously improved SDLC processes along the Maturity dimension. This way, our Clients can develop products faster, more flexibly, yet still meeting regulatory requirements for medical devices.

Contact us and learn how Pro4People can become
your partner in Medical Device Software Development

Quality Management System Scope

Our SDLC service operates under the ISO 13485 certified Quality Management System. Our QMS has been certified by Lloyd’s Register. The scope of our certification is defined as

“Design and development of medical device and health software for medical device manufacturers”

Pro4People’s Certificate of Approval

In addition to that, our QMS fulfils the requirements of ISO 14971 – Medical Devices – Application of risk management to medical device standard. Even though we usually follow Clients’ Risk Management System (RMS) in Design and Development, we do make sure that every team member is aware of, and competent in that domain, crucial for medical device development.

Pro4People’s QMS operates on ins2outs platform – an online Organization Management System used to execute daily project activities. Our Clients work with us jointly on the platform, and have all the required documents and records delivered at the agreed project milestones. Additionally, our Information Security Management System is also certified with the requirements of ISO27001 standard.

Quality Management Policy

In case you would like to learn more about Pro4People Quality Management Policy, please click on the attached document. It explains the cornerstone of our approach to managing quality in medical device and health software products.

Pro4People’s Quality Management Policy

Learn how Pro4People can help you
in Medical Device Software Development

 

Initiating Design and Development

At the beginning of Design and Development project, it is very important to mutually understand the Client’s and Pro4People’s QMS boundaries, and agree on where they should be drawn. Thus, whenever we start a new project, we initiate it with around 2-week pre-development phase. It aims at agreeing which QMS, and in what scope, shall be followed, as well as preparing formal design and development inputs. From Pro4People perspective, all options are possible in respect of the process tailoring:

  1. Working fully under Client’s QMS
  2. Working in Design and Development under Pro4People’s QMS
  3. Any hybrid solution of the above two options

Such a decision is then documented in Process Tailoring activity, allowing each side of Product Life Cycle to understand its responsibilities and resulting deliverables.

Design and Development

We manage Design and Development phase as a project. Pro4People will deliver a fully staffed project team capable of developing modern software solutions for medical devices. The team will be fully responsible for both technical and regulatory aspects of a project. The project is divided into formal milestones used to control its progress and compliance with ISO 13485 requirements.

For example, at the Version Verified milestone, a full product SDLC Release Package with all documents and records from product Verification is delivered to Product Team as the output of Design and Development activities.

Design and Development ends when the Client finishes and approves Validation of the released and securely transferred product release package. As an outcome, Pro4People delivers a working engineering solution as well as all documents and records required to prove the following applicable SDLC / QMS processes.

Let’s talk about your project

Information Note

Pro4People sp. z o.o., based in Wrocław, Poland at Wołowska 18 (postal code 51-116), will be the controller of your entrusted personal data. Your personal data will be processed for the period of 3 years from the moment of the last contact. Your data will be processed under the General Data Protection Regulation (GDPR) and derived Polish national regulations. The base for processing is your consent, thus you can execute all the individual rights derived from GDPR at any moment by contacting us at gdpr@pro4people.com. Pro4People may transfer your personal data only to its Trustworthy Suppliers providing supplementary services to us for the purpose specified in this consent.

Pro4People Sp. z o.o.

If you prefer to reach us directly,
you can send us an email or call us:

info@pro4people.com
+48 663 466 030

Our office is located in Poland/Europe
and we operate from 9 to 17 (UTC+2).