ISO 13485:2016 is designed specifically for medical device companies and recognised worldwide as the quality management standard. ISO does not perform certification audits or issue certificates. This is carried out by a notified body or registrar. Therefore certification automatically improves the perception of your company and its products and is required for product marketing in most countries.
The idea behind ISO standards is to make the quality management system clear by showing how company processes relate to ISO 13485:2016 standards.
This can be best achieved by appointing a quality management consultant to act on your behalf to ensure you have the right systems in place and liaise with the registration authority.
Vague and poorly organised documentation create confusion, misunderstanding and can lead to costly regulatory penalties.
More importantly, poor documentation can cause delays to product launch.
Well-designed and clearly written documentation helps:
- Save time
- Reduce errors
- Prevent penalties
- Provide effective employee training
- Shows commitment to continual improvement
- Increases customer confidence in ability to bring safe and effective products to market
Clear training and understandable SOPs helps build employee confidence and job satisfaction by making it easier to understand their roles and reporting responsibilities. This results in better communication and productivity.
Quick certification often means quicker access to EU markets
Having a quality management system based on ISO 13485 standards at an early stage can help gain regulatory approvals from a variety of EU countries. The longer medical device manufacturers stay in the review stage, the more costly delays become.
Benefits of ISO 13485 for medical device manufacturers:
- Increases customer confidence
Certification establishes a company’s commitment to quality, which often leads to increased customer confidence
- Improves marketing and promotional opportunities
A certified company will receive a certificate. This can displayed on all marketing materials to improve credibility and gain a competitive advantage
- Products to market quicker
ISO 13485 certification allows medical device manufacturers meet quality system requirements of the European Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EEC) and Active Implantable Medication Device Directive (90/385/EEC) with less difficulty, which speeds up product launches
- Promotes better communication and fewer deviations
ISO 13485 promotes harmonisation of regulatory requirements on an international scale. Harmonisation allows medical device manufacturers and other quality experts to communicate using a standardised language.
This helps avoid misunderstandings resulting in deviations, non-conformances and other quality events that could cause patient harm, regulatory sanctions and loss of revenue
- Improves business performance
Improved products and processes help device manufacturers deliver high quality products without embarrassing product recalls and costly regulatory sanctions. This leads to increased customer satisfaction and better relationships with suppliers and stakeholders
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