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GOALS

Medical Device Consulting

We help Medtech Companies in achieving their compliance and market access goals.
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Quality, Ethics and Compliance

Quality, Ethics and Compliance

goals medical device consulting

About us

Since 2016 we provide tailored services for the medical device industry: whether you require support, consulting or simply additional resources for your Quality, Regulatory Affairs or Sterilization project, our fast-pacing team is able to assist you with custom, result oriented solutions.

We are passionate about QUALITY, ETHICS AND COMPLIANCE !

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Custom solutions

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Compliance

Our services

Our consultants will assist you in facing challenges and seize opportunities in the fields of:

Regulatory Compliance

In a highly regulated, high-risk industry like healthcare, compliance is especially important and involves entire product's lifecycle from idea to decommissioning.

CE Marking of Conformity

CE marking is the medical device manufacturer's claim that a product meets the essential requirements of relevant European Medical Device Directive and is a legal requirement to place a device on the market in the EU but could also used to facilitate registrations outside of EU.

MDR (Council Regulation 2017/745) Transition

The long awaited European Medical Devices Regulation (Council Regulation 2017/745) which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), entered into force on May 25th 2017, marking the start of the 3 years transition period for manufacturers selling medical devices into Europe. Are you preparing to comply by May 2020 ?

Quality Management System Implementation

The ISO 13485 standard is a voluntary but effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides to manufacturers and other economical operators a practical pathway demonstrating their commitment to the safety and quality of medical devices.

Risk Management

Medical device companies MUST have established risk management processes that comply with ISO 14971 and with EU regulation.

Medical Device Sterilization

Terminal sterilization for medical devices can be achieved through a variety of technologies; which is the most appropriate method for your device? How to validate the method in order to ensure product safety?

Competitive advantages of quality, ethics and compliance.

Attract new business partners and retain existing ones

Our qualified consultants have been working for more than 20 years delivering successful business solutions in the Medical Device Industry.

Increase business value

We use the unique approach tailored to your requirements to achieve the best results for your company.

Reduce business risk

Business risk is a growing concern, especially in today’s economy.

Build a solid reputation

Quality should be at the forefront of your reputation agenda, regardless of what end of the market you operate.

Get in touch

Phone

+39 334 135 2324

E-mail

info@goalsmed.com

E-mail

consulting@goalsmed.com

PEC

goals.srl@pec.it

GOALS
Medical Device Consulting
  • VAT: IT01846120887
  • Fiscal Code: 01846120887
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