As all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms that want to create and maintain marketable product lines must be willing to subject themselves to intense regulatory scrutiny. They also have to comply with a range of rules pertaining to quality assurance, information technology, supply chain management and other fields.
Medical device compliance consulting is one of the tools these companies rely on to ensure that they’re on the right track, and it encompasses a number of important methodologies.
Applying Comprehensive Strategies
The most effective compliance strategies begin and end with standards. Compliance consultants start by going through the huge body of different requirements and guidelines to identify which are applicable to the medical device manufacturer in question.
After an initial assessment has been performed and problems are identified, improvement recommendations can be given. Once these have been implemented, the firm’s adherence to the previously identified standards can be continually reassessed to minimize gaps.
This strategy is applicable to a number of sub-fields. For instance, supply chain assessments that identify requirements based on the regulatory rules of the target market can be used to evaluate and qualify individual suppliers and contracts.
After issues are quantified, supply chain elements and parties can be routinely audited to ensure continued satisfactory performance. Supplier audits are a common tool for improving quality, and knowledgeable consultants often perform them to mitigate potential risks.
Why Not Simply Target Known Problems?
Although it seems like an obvious strategy, it’s highly ineffective to selectively pursue the issues you’re already aware of. The existence of such problems may be indicative of others, and targeting them after the fact is a very poor way to prevent future recurrences. Furthermore, applying fixes, without extensive consideration of the problem, may leave root causes unsolved or lead to the creation of a compliance system, which may no longer be logical in its approach.
Compliance consultants help firms devise holistic strategies that apply to the unknown as well as established deficiencies. The qualification and product validation methodologies that manufacturers use are carefully evaluated so that they can be managed more intelligently. Such evaluations often drive the implementation of improved management and tracking software, clarify the need for FDA-mandated Corrective and Preventative Actions, and help firms benefit from other vital tools that can be used to ensure backwards compliance as well as deal with new issues.
Who Needs Medical Device Compliance Consulting?
Compliance consulting isn’t just for companies that know they need to improve because they’ve received 483’s or a Warning Letter from the FDA. Device manufacturers that want to break into new markets, such as those in the European Union, also take advantage of consulting. The objective viewpoint that consultants offer may give these companies a better handle on the changes they’ll need to make along the way and help them devise a cost-effective strategy for implementing new standards.
Compliance consulting plays a critical role in making medical device manufacturing more economical. By helping firms assess every aspect of their operational strategies, it ensures that they can adopt a proactive, all-inclusive approach to continued improvement.
GxP-CC is a leading firm of compliance consultants helping medical device, pharmaceutical and dental lab manufacturers meet FDA and EU requirements. Contact them today to discuss your needs in reaching compliance for your product.